Specialty Pipeline Quarterly Update: June 2022

July 13, 2022

This 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

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