Perspectives
Specialty Pipeline Quarterly Update: June 2022
July 13, 2022This pipeline wrap-up provides a review of newly approved specialty drugs, recent specialty drug launches, new indications and news of note on specialty drugs in the approval process. See separate articles for pipeline information on traditional drugs.
New Drug Information
- Fylnetra® (pegfilgrastim-pbbk): The FDA approved Amneal’s Fylnetra (pegfilgrastim-pbbk) a leukocyte growth factor biosimilar to Neulasta® (pegfilgrastim) used to reduce the incidence of neutropenia in patients undergoing chemotherapy. Fylnetra is the fifth Neulasta biosimilar, other biosimilars include: Mylan/Biocon’s Fulphila® (pegfilgrastim-jmdb), Pfizer’s Nyvepria™ (pegfilgrastim-apgf), Coherus BioSciences’ Udenyca® (pegfilgrastim-cbqv) and Sandoz’s Ziextenzo® (pegfilgrastim-bmez) which are already available in the U.S. None of the biosimilars are interchangeable with Neulasta or with each other.1 According to IQVIA®, U.S. annual sales for pegfilgrastim for the 12 months ended March 2022 were $3.1 billion, $1.0 billion of which represented biosimilar sales.2 Amneal is planning on launching Fylnetra the second half of 2022 with pricing to follow.
- Amvuttra® (vutrisiran): The FDA approved Amvuttra (vutrisiran), an RNAi therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. hATTR amyloidosis is a rare, inherited, rapidly progressive, and fatal disease with debilitating polyneuropathy manifestations, for which there are few treatment options. Amvuttra is administered via subcutaneous healthcare administered injection, once every three months. The FDA approval is based on positive 9-month results from the HELIOS-A Phase 3 study, where Amvuttra significantly improved the signs and symptoms of polyneuropathy. Amvuttra met the primary endpoint of the study, the change from baseline in the modified Neuropathy Impairment Score + 7 (mNIS+7) at 9 months. Treatment with Amvuttra resulted in a 2.2 point mean decrease (improvement) in mNIS+7 from baseline as compared to a 14.8 point mean increase (worsening) reported for the external placebo group, resulting in a 17.0 point mean difference relative to placebo; by 9 months, 50 percent of patients treated with Amvuttra experienced improvement in neuropathy impairment relative to baseline.3 Amvuttra is scheduled to launch early July with pricing to follow.
- Tyvaso DPI® (treprostinil dry powder for inhalation): The FDA approved a new formulation of United Therapeutics’ Tyvaso DPI (treprostinil dry powder for inhalation) for treatment of pulmonary arterial hypertension (PAH; WHO Group 1 pulmonary hypertension) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3 pulmonary hypertension). Tyvaso DPI was approved based Phase 1 BREEZE study that demonstrated that the transition from Tyvaso inhalation solution to Tyvaso DPI was safe and well tolerated.4 The Tyvaso DPI Inhaler can be used for up to seven days from the date of first use, after which it must be discarded and replaced with a new inhaler. Tyvaso DPI is expected to be available in June 2022 with pricing to follow.
New Indications
- Evrysdi® (risdiplam): The FDA expanded Genentech’s Evrysdi (risdiplam) indication to include pre-symptomatic babies under 2 months of age with spinal muscular atrophy (SMA).
- Tibsovo® (ivosidenib): The FDA expanded the indication for Agios Pharmaceuticals’ Tibsovo (ivosidenib) to be used in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
- Vidaza® (azacitadine): Bristol Myers Squibb’s Vidaza (azacitadine) has been approved by the FDA to include a new indication for treatment of pediatric patients aged one month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML).
- Dupixent® (dupilumab): The FDA approved an additional indication for Sanofi Pharmaceuticals’ Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds).
- Olumiant® (baricitinib): The FDA expanded the indication of Lilly and Incyte’s Olumiant (baricitinib) to include the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Additionally, the FDA added the treatment of alopecia areata to the indications for Olumiant.
June News
- “Two years after the FDA turned back BioMarin’s push for a landmark accelerated approval of their hemophilia A gene therapy valrox, regulators are asking for still more info on the therapy — and once again delaying any prospective launch, this time into next year. Buried under the latest set of extended data from their Phase 1/2 trial of valrox (valoctocogene roxaparvovec), which continues to demonstrate its effectiveness in preventing bleeds up to six years after initial treatment, the biotech spelled out the reasons why they’re shoving back an expected resubmission from June to September. The agency wants more data and analysis, says the biotech, but isn’t asking for any new studies. And the news will likely enhance some deep-seated concerns that the FDA appears to be in no rush to approve any gene therapy overshadowed by questions of durability and safety.”5
- “The four companies working on gene therapies for Duchenne muscular dystrophy (DMD) have had another thing in common besides the modality and disease they’re working on: serious adverse events. Rather than continue to plug away at individual studies and try to figure out why these side effects were happening in certain patients, Pfizer, Sarepta, Genethon and Solid Biosciences teamed up for a pooled safety analysis (PDF) that was presented this week at the American Society of Gene and Cell Therapy meeting. The companies shared clinical and laboratory data and put together a panel of experts to take a look with the goal of minimizing further medical complications.”6
- “Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, we determined the risks of treatment with Ukoniq outweigh its benefits.”7
- “Roughly 24 hours after Canadian regulators gave Amylyx Pharmaceuticals the thumbs-up for its new ALS drug, ICER is out with a new analysis trying to determine whether the drug would be cost effective. And the short answer is no — for now. Though Amylyx has not disclosed how much it intends to charge for the drug, branded as Albrioza, ICER pegged its estimated cost to an older ALS medicine, edaravone. If Albrioza costs $169,000 per year, as edaravone currently does, the drug would not be cost effective to the US healthcare system, and far from it, ICER says. Using a measurement known as quality-adjusted life year, or QALY, ICER said in its draft report that Albrioza would only be cost effective if priced at $13,700 annually — less than 10% of edaravone’s price point. QALY represents the best estimation of the value of a year of good health, Rind said, combining length of life and quality of life into a single measure when given a certain treatment. In general, ICER uses $150,000 as the benchmark for how much US patients or insurers are willing to pay for an extra year of good health, Rind said. Albrioza would be more cost effective, however, than the oral formulation of edaravone, recently approved by the FDA, ICER says oral edaravone should be priced at $2,200 per year to achieve cost effectiveness.”8
SPECIALTY NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Admin | Month Approved | |
vutrisiran | Amvuttra® | Alnylam Pharmaceuticals | Polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis | SC | June 2022 | |
edaravone, oral | Radicava ORS® | Mitsubishi Tanabe Pharma | Amyotrophic lateral sclerosis (ALS) | Oral | May 2022 | |
trientine tetrahydro-chloride | Cuvrior™ | Orphalan | Wilson’s disease | Oral | May 2022 | |
treprostinil dry powder for inhalation | Tyvaso DPI® | United Therapeutics Corp | New dry powder formulation of for treatment of pulmonary arterial hypertension | Inhaled | May 2022 | |
mavacamten | Camzyos® | Bristol-Myers Squibb | Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) | Oral | April 2022 | |
ganaxolone | Ztalmy™ | Marinus Pharmaceuticals, Inc. | Seizures associated with CDKL5 deficiency disorder (CDD) | Oral | March 2022 | |
mitapivat | Pyrukynd® | Agios Pharmaceuticals | Pyruvate kinase (PK) deficiency | Oral | February 2022 | |
sutimlimab-jome | Enjaymo® | Sanofi US | Cold agglutinin disease (CAD) | IV | February 2022 | |
faricimab-svoa | Vabysmo® | Genentech | Diabetic macular edema | Intravitreal | January 2022 | |
abrocitinib | Cibinqo® | Pfizer And Lilly | Atopic dermatitis | Oral | January 2022 | |
inclisiran | Leqvio® | Novartis | Hyperlipidemia | SC | January 2022 | |
tezepelumab | Tezspire® | AstraZeneca and Amgen | Asthma across phenotypes | SC | January 2022 | |
tralokinumab-ldrm | Adbry® | Leo Pharma Inc | Atopic dermatitis | SC | December 2021 | |
Levoketocon-azole | Recorlev® | Strongbridge Biopharma | Cushing’s syndrome | Oral | December 2021 | |
efgartigimod alfa-fcab | Vyvgart® | Argenx | Generalized myasthenia gravis | IV | December 2021 | |
budesonide | Tarpeyo® | Calliditas Therapeutics | Primary IgA nephropathy (IgAN) | Oral | December 2021 | |
vosoritide | Voxzogo® | BioMarin | Achondroplasia | SC | November 2021 | |
ropeginterferon alfa-2b-njft | Besremi® | PharmaEssentia | Polycythemia vera (PV) | SC | November 2021 | |
treprostinil inhalation powder | Yutrepia®
Tentative approval |
Liquidia | Pulmonary arterial hypertension | Inhaled dry powder | November 2021 | |
ranibizumab via ocular implant | Susvimo® | Genentech | Age-related macular degeneration | Intravitreal injection | October 2021 | |
triamcinolone acetonide | Xipere® | Clearside Biomedical and Bausch + Lomb (Bausch Health) | Macular edema associated with uveitis | Suprachoroidal injection | October 2021 | |
avacopan | Tavneos® | Chemocentryx | ANCA-associated vasculitis | Oral | October 2021 | |
allogeneic processed thymus tissue-agdc | Rethymic® | Enzyvant (Sumitomo Dainippon, Sumitovant) | Certain forms of congenital athymia | Surgical | October 2021 | |
maralixibat | Livmarli® | Mirum Pharmaceuticals | Alagille syndrome (ALGS) | Oral | September 2021 | |
ruxolitinib cream | Opzelura® | Incyte Corporation | Atopic dermatitis | Topical | September 2021 | |
lonapegsomatropin | Skytrofa® | Acendis | Pediatric growth hormone deficiency (GHD) | SC | September 2021 | |
avalglucosidase alfa | Nexviazyme® | Sanofi-Aventis | Pompe disease | IV | August 2021 | |
anifrolumab-fnia | Saphnelo® | AstraZeneca | Systemic lupus erythematosus (SLE) | IV | August 2021 | |
selexipag | Uptravi® | Johnson & Johnson | Pulmonary arterial hypertension | IV | July 2021 | |
odevixibat | Bylvay® | Albireo | Progressive familial intrahepatic cholestasis | Oral | July 2021 | |
belumosudil | Rezurock® | Kadmon | Chronic graft-versus-host disease (cGVHD) | Oral | July 2021 |
NEW INDICATIONS FOR APPROVED SPECIALTY PRODUCTS
Generic name | Brand name | Manufacturer | New Indication(s) | Date approved* | |
baricitinib | Olumiant® | Lilly and Incyte | Alopecia areata | June 2022 | |
risdiplam | Evrysdi® | Genentech | Pre-symptomatic babies under 2 months of age with Spinal Muscular Atrophy (SMA) | May 2022 | |
dupilumab | Dupixent® | Sanofi Pharmaceuticals | To treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds) | May 2022 | |
baricitinib | Olumiant® | Lilly and Incyte | For the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) | May 2022 | |
upadacitinib | Rinvoq® | Abbvie | Adults with active ankylosing spondylitis | April 2022 | |
ravulizumab-cwvz | Ultomiris® | AstraZeneca (Alexion) | Generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive | April 2022 | |
remdesivir | Veklury® | Gilead | Certain pediatric patients 28 days of age and older weighing at least 3 kilograms with positive results of direct SARS-CoV-2 viral testing | April 2022 | |
upadacitinib | Rinvoq® | Abbvie | Moderately to severely active ulcerative colitis | March 2022 | |
tocilizumab | Actemra® IV | Genentech | Adults with giant cell arteritis | February 2022 | |
von Willebrand factor, recombinant | Vonvendi® | Takeda | Bleeding episodes in adults with von Willebrand disease (VWD) | January 2022 | |
risankizumab-rzaa | Skyrizi® | Abbvie | Treatment of adults with active psoriatic arthritis | January 2022 | |
upadacitinib | Rinvoq® | Abbvie | Adults and adolescents with moderate to severe atopic dermatitis (eczema) | January 2022 | |
secukinumab | Cosentyx® | Novartis | Active enthesitis-related arthritis in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older | December 2021 | |
apremilast | Otezla® | Amgen | Mild to moderate plaque psoriasis who are candidates for phototherapy or systemic therapy | December 2021 | |
voxelotor | Oxbryta® | Global Blood Therapeutics, Inc | Pediatric indication and new dispersible tablet for oral suspension dosage form of the sickle hemoglobin polymerization inhibitor for treatment of sickle cell disease (SCD) in patients aged 4 to 11 years | December 2021 | |
abatacept | Orencia® | BMS | Prophylaxis of acute graft versus host disease (aGVHD) in combination | December 2021 | |
tofacitinib | Xeljanz® | Pfizer | Ankylosing spondylitis (AS) | December 2021 | |
upadacitinib | Rinvoq® | Abbvie | Psoriatic arthritis | December 2021 | |
dupilumab | Dupixent® | Sanofi and Regeneron | Add-on treatment of pediatric patients aged six to 11 years of age with uncontrolled moderate-to-severe asthma | October 2021 | |
bictegravir, emtricitabine and tenofovir alafenamide | Biktarvy® | Gilead | Expanded pediatric indication for the integrase strand transfer inhibitor (INSTI)-based single-tablet regimen and new low-dose tablet formulation for treatment of HIV-1 infected pediatric patients weighing at least 14 kg | October 2021 | |
ruxolitinib | Jakafi® | Incyte | Steroid-refractory chronic graft versus host disease (SR chronic GVHD) in adults and pediatric patients 12 years and older | September 2021 | |
calcium, magnesium, potassium and sodium oxybates | Xywav® | Jazz Pharmaceuticals | Idiopathic hypersomnia | August 2021 | |
mepolizumab | Nucala® | Glaxo Smith Kline | Chronic rhinosinusitis with nasal polyps | July 2021 | |
tacrolimus | Prograf® | Astellas Pharma | Prevent organ rejection in adult and pediatric patients receiving lung transplantation | July 2021 |
ONCOLOGY PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Admin | Date Approved |
bortezomib | Bortezomib® | Hospira | Multiple myeloma
Mantle cell lymphoma |
IV or SC | May 2022 |
alpelisib | Vijoice® |
Novartis
|
Severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) | Oral | April 2022 |
lutetium Lu 177 vipivotide tetraxetan | Pluvicto® | Novartis | Prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) | IV | March 2022 |
sirolimus topical gel | Hyftor® | Nobelpharma | Facial angiofibroma | Gel | March 2022 |
relatlimab and nivolumab | Opdualag® | Bristol Myers Squibb | Certain forms of metastatic melanoma | IV | March 2022 |
pacritinib | Vonjo® | CTI BioPharma | Myelofibrosis patients with severe thrombocytopenia | Oral | February 2022 |
tebentafusp-tebn | Kimmtrak® | Immunocore | Metastatic uveal melanoma (mUM) | IV | January 2022 |
cabazitaxel | N/A | Accord | Metastatic castration-resistant prostate cancer | IV | December 2021 |
sirolimus albumin-bound nanoparticles for injectable suspension | Fyarro® | Aadi Bioscience | Metastatic or locally advanced malignant perivascular epithelioid cell tumor (PEComa) | IV | November 2021 |
asciminib | Scemblix® | Novartis | Certain forms of chronic myeloid leukemia (CML) | Oral | October 2021 |
tisotumab
vedotin-tftv |
Tivdak® | Seagen | Certain forms of cervical cancer | IV | September 2021 |
mobocertinib | Exkivity® | Takeda Pharmaceuticals | Metastatic non-small cell lung cancer (mNSCLC) | Oral | September 2021 |
belzutifan | Welireg® | Merck | Von Hippel-Lindau (VHL) disease | Oral | August 2021 |
dostarlimab-gxly | Jemperli™ | GlaxoSmithKline (Tesaro) and AnaptysBio | Certain forms of solid tumors | IV | August 2021 |
NEW INDICATIONS FOR APPROVED ONCOLOGY DRUGS
Generic name | Brand name | BRAND Manufacturer | Indication(s) | approval date* | |
ivosidenib | Tibsovo® | Agios Pharmaceuticals | In combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy | May 2022 | |
azacitadine | Vidaza® | Bristol Myers Squibb (Celgene) | New indication for the nucleoside metabolic inhibitor for treatment of pediatric patients aged one month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML) | May 2022 | |
axicabtagene ciloleucel | Yescarta® | Kite | Second line treatment of adults with R/R large B-cell lymphoma | April 2022 | |
pembrolizumab | Keytruda® | Merck | Advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation | March 2022 | |
olaparib | Lynparza® | AstraZeneca and Merck | BRCA-mutated, HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery | March 2022 | |
nivolumab | Opdivo® | Bristol Myers Squibb | Combination with chemotherapy for adult patients with non-small cell lung cancer (NSCLC) in the neoadjuvant setting | March 2022 | |
rituximab | Rituxan® | Genentech | B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia | December 2021 | |
pembrolizumab | Keytruda® | Merck | Stage IIB or IIC melanoma | December 2021 | |
pembrolizumab | Keytruda® | Merck | Adjuvant treatment of renal cell carcinoma (RCC) | November 2021 | |
atezolizumab | Tecentriq® | Roche (Genentech) | Stage II-IIIA non-small cell lung cancer (NSCLC) | October 2021 | |
pembrolizumab | Keytruda® | Merck | Combination with chemotherapy, with or without bevacizumab, treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 | October 2021 | |
abemaciclib | Verzenio® | Lilly | In combination with endocrine therapy (tamoxifen or aromatase inhibitor) for adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) | October 2021 | |
brexucabtagene autoleucel | Tecartus® | Gilead Sciences | Adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) | October 2021 |
BIOSIMILAR PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name | Brand Name | Reference
Product |
Manuf-acturer | Indication (s) | Route of Admin | Month Approved |
pegfilgrastim-pbbk | Fylnetra™ | Neulasta® | Amneal and Kashiv (Adello) | Neutropenia | IV or SC | May 2022 |
bevacizumab-maly | Alymsys™ | Avastin® | mAbxience, Insud Pharma; Amneal | Oncology | IV | April 2022 |
filgrastim-ayow | Releuko™ | Amneal | Neutropenia | Blood modifying | IV | February 2022 |
insulin glargine-aglr | Rezvoglar™ | Lantus® | Eli Lilly | Diabetes | SC | December 2021 |
adalimumab-aqvh | Yusimry™ | Humira® | Coherus | Autoimmune | SC | December 2021 |
ranibizumab-nuna | Byooviz™ | Lucentis® | Samsung Bioepis | Age related macular degeneration | Intra-vitreal | September 2021 |
insulin glargine-yfgn
First interchange-able biosimilar for Lantus |
Semglee™ | Lantus® | Mylan and Biocon | Diabetes | SC | July 2021 |
pegfilgrastim-pbbk | Fylnetra™ | Neulasta® | Amneal and Kashiv (Adello) | Neutropenia | IV or SC | May 2022 |
bevacizumab-maly | Alymsys™ | Avastin® | mAbxience, Insud Pharma; Amneal | Oncology | IV | April 2022 |
filgrastim-ayow | Releuko™ | Amneal | Neutropenia | Blood modifying | IV | February 2022 |
insulin glargine-aglr | Rezvoglar™ | Lantus® | Eli Lilly | Diabetes | SC | December 2021 |
adalimumab-aqvh | Yusimry™ | Humira® | Coherus | Autoimmune | SC | December 2021 |
ranibizumab-nuna | Byooviz™ | Lucentis® | Samsung Bioepis | Age related macular degeneration | Intra-vitreal | September 2021 |
insulin glargine-yfgn
First interchange-able biosimilar for Lantus |
Semglee™ | Lantus® | Mylan and Biocon | Diabetes | SC | July 2021 |
SPECIALTY PIPELINE
Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Admin | Anticipated Approval date* | |
eflornithine and sulindac | Flynpovi® | Cancer Prevention Pharmaceuticals | Familial adenomatous polyposis (FAP) | Oral | Delayed | |
donislecel purified allogeneic deceased donor pancreas derived islets of Langerhans | Lantidra® | CellTrans | Brittle type 1 diabetes | IV | Delayed | |
SH-111 | N/A | Shorla Pharma | Pediatric patients with T-cell leukemia | IV | Delayed | |
FT218 (sodium oxybate, controlled release) | N/A | Avadel Pharmaceuticals | Narcolepsy | Oral | Delayed | |
inolimomab | Leukotac® | Farmaceutici Spa | Steroid-refractory acute graft-versus-host disease | IV | Delayed | |
Efbemaleno-grastim alfa | Ryzneuta™ | Evive Biotech | Chemotherapy-induced neutropenia | SC | Delayed | |
penpulimab | N/A | Akeso and Sino Biopharmaceutical | Metastatic nasopharyngeal carcinoma | IV | Delayed | |
spesolimab | N/A | Boehringer Ingelheim | Generalized pustular psoriasis (GPP) flares | IV | June 2022 | |
sodium phenylbutyrate | N/A | Acer Therapeutics and Relief Therapeutics | Urea cycle disorders (UCDs) | Oral | June 2022 | |
tislelizumab | N/A | BeiGene and Novartis | Certain forms of esophageal squamous cell carcinoma (ESCC) | Injection | July 2022 | |
olipudase alfa | N/A | Sanofi (Genzyme) | Acid sphingomyelinase deficiency (ASMD) | IV | July 2022 | |
teplizumab | Tzield™ | Provention Bio | Diabetes | IV | August 2022 | |
miglustat (for AT-GAA combination with cipaglucosidase alfa) | N/A | Amicus Therapeutics | Pompe disease | Oral | August 2022 | |
teclistamab | N/A | Johnson & Johnson (Janssen) | Relapsed or refractory multiple myeloma | IV or SC | August 2022 | |
sodium phenylbutyrate and taurursodiol | N/A | Amylyx Pharmaceuticals, Inc. | Amyotrophic lateral sclerosis (ALS) | Oral | September 2022 | |
deucravacitinib | N/A | Bristol Myers Squibb | Plaque psoriasis | Oral | September 2022 | |
RBX2660 | N/A | Ferring (Rebiotix) | Clostridioides difficile (C diff) infection | Rectal | September 2022 | |
sodium thiosulfate, STS | Pedmark™ | Fennec Pharmaceuticals | Prevention of ototoxicity induced by cisplatin | IV | September 2022 | |
futibatinib | N/A | Taiho Oncology | Metastatic cholangiocarcinoma | Oral | September 2022 | |
eflapegrastim | Rolontis™ | Spectrum Pharmaceuticals and Hanmi Pharmaceutical | Chemotherapy-induced neutropenia | SC | September 2022 | |
subcutaneous furosemide, sc2Wear furosemide infusor-drug/device combination | Furoscix™ | ScPharmaceuticals | Diuresis in patients with worsening heart failure | SC minipump | October 2022 | |
treosulfan | N/A | Medac GmbH and Medexus | Reduced toxicity conditioning in certain conditions | IV | October 2022 | |
tremelimumab | N/A | AstraZeneca | Certain forms of unresectable hepatocellular carcinoma | IV | October 2022 | |
cipaglucosidase alfa (in combination with miglustat) | N/A | Amicus Therapeutics | Pompe disease | IV | October 2022 | |
SPN-830 (apomorphine infusion pump) | N/A | Supernus Pharmaceuticals | Parkinson’s disease | SC Minipump | October 2022 | |
sparsentan | N/A | Travere Therapeutics | IgA nephropathy (IgAN) | Oral | November 2022 | |
poziotinib | N/A | Spectrum Pharmaceuticals, Inc. | Certain forms of metastatic non-small cell lung cancer (NSCLC) | Oral | November 2022 | |
mirvetuximab soravtansine | N/A | ImmunoGen | Certain forms of folate receptor alpha-high platinum-resistant ovarian cancer | IV | November 2022 | |
omaveloxolone | N/A | Reata Pharmaceuticals, Inc. | Friedreich’s ataxia | Oral | November 2022 | |
ublituximab | N/A | TG Therapeutics | Certain forms of chronic lymphocytic leukemia (CLL) | IV | December 2022 | |
adagrasib | N/A | Mirati Therapeutics | Second-line treatment of advanced non-small cell lung cancer (NSCLC) | Oral | December 2022 | |
ublituximab | N/A | TG Therapeutics | Relapsing multiple sclerosis | IV | December 2022 | |
daprodustat | N/A | GlaxoSmithKline | Anemia of chronic kidney disease (CKD) | Oral | February 2023 |
BIOSIMILAR PIPELINE
Generic Name | Brand Name | Manufacturer | Indication(s) | Route of
Admin |
Anticipated Approval date* | ||||
Oncology | |||||||||
MYL-1402O | N/A (Avastin® biosimilar) | Mylan NV and Biocon Ltd. | Oncology | IV | 2022 | ||||
SB8 | N/A (Avastin® biosimilar) | Samsung Bioepis and Merck | Oncology | IV | 2022 | ||||
FKB238 | N/A (Avastin® biosimilar) | Centus Biotherapeutics | Oncology | IV | 2022 | ||||
BAT-1706 | N/A (Avastin® biosimilar) | Bio-thera solutions | Oncology | IV | 2022 | ||||
CT-P16 | N/A (Avastin® biosimilar) | Celltrion | Oncology | IV | 2022 | ||||
EG12014 | N/A (Herceptin® biosimilar) | Sandoz | Oncology | IV | 2022 | ||||
TX05 | N/A (Herceptin® biosimilar) | Tanvex | Oncology | IV | 2022 | ||||
Blood Modifiers | |||||||||
MSB11455 | Stimufend® (Neulasta® biosimilar) | Fresenius Kabi | Neutropenia | IV or SC | 2022 | ||||
lupifil-p | N/A (Neulasta® biosimilar) | Lupin | Neutropenia | SC | 2022 | ||||
lapelga | N/A (Neulasta® biosimilar) | Apotex/Accord | Neutropenia | SC | 2022 | ||||
TX01 | N/A (Neupogen® biosimilar) | Tanvex BioPharma | Neutropenia | SC | 2022 | ||||
grastofil | N/A (Neupogen® biosimilar) | Apotex/Accord | Neutropenia | SC | 2022 | ||||
Ophthalmology | |||||||||
FYB201 | Cimerli® (Lucentis® biosimilar) | Coheres biosciences /bioeq |
Age-related macular degeneration | Injection into the eye | 2022 | ||||
xlucane | N/A (Lucentis® biosimilar) | Xbrane & Bausch | Age-related macular degeneration | Injection into the eye | 2023 | ||||
MYL-1701P | N/A (Eylea® biosimilar) | Mylan | Age-related macular degeneration | Injection into the eye | 2022 |
REFERENCES
- https://endpts.com/look-out-neulasta-a-5th-biosimilar-is-coming/
- https://www.drugs.com/newdrugs/fda-approves-fylnetra-pegfilgrastim-pbbk-biosimilar-neulasta-5838.html
- https://www.businesswire.com/news/home/20220603005487/en/Alnylam-Announces-FDA-Approval-of-AMVUTTRA%E2%84%A2-vutrisiran-an-RNAi-Therapeutic-for-the-Treatment-of-the-Polyneuropathy-of-Hereditary-Transthyretin-Mediated-Amyloidosis-in-Adults
- https://www.empr.com/home/news/treprostinil-gets-fda-approval/
- https://endpts.com/once-again-the-fda-is-putting-biomarins-hemophilia-a-quest-on-hold-as-gene-therapy-frets-simmer/
- https://www.fiercebiotech.com/biotech/pfizer-sarepta-team-fellow-dmd-gene-therapy-makers-get-bottom-adverse-events
- https://www.fda.gov/drugs/drug-safety-and-availability/fda-approval-lymphoma-medicine-ukoniq-umbralisib-withdrawn-due-safety-concerns
- https://endpts.com/in-draft-report-icer-says-amylyxs-als-drug-would-not-be-cost-effective-if-priced-similarly-to-older-treatment/
Related news
Perspectives
September 25, 2023
Specialty Drug Pipeline Quarterly Update: September 2023
This monthly pipeline wrap-up provides a review of newly approved specialty drugs, recent…
Perspectives
September 25, 2023
Traditional Drug Pipeline Quarterly Update: September 2023
This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent…
Perspectives
September 25, 2023
Gene/Cell Therapy Quarterly Update: September 2023
This quarterly pipeline wrap-up provides a review of newly approved gene and cell…