Specialty Pipeline Update: March 2022

March 29, 2022

New drugs, new indications and news of note

This monthly 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 article for pipeline information on traditional drugs.

New Drug Information

Pyrukynd®(mitapivat): U.S. Food and Drug Administration (FDA) has approved Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, a rare, debilitating, lifelong hemolytic anemia. Pyrukynd is a first-in-class, oral PK activator and the first approved disease-modifying therapy for this disease. The Phase 3 ACTIVATE trial of Pyrukynd achieved its primary endpoint by demonstrating a statistically significant increase in hemoglobin in patients with PK deficiency who are not regularly transfused with 40% of patients randomized achieving a hemoglobin response, compared to 0 patients randomized to placebo. The Phase 3 ACTIVATE-T trial of Pyrukynd also achieved its primary endpoint of demonstrating a statistically significant and clinically meaningful reduction in transfusion burden for patients who are regularly transfused (33% of patients achieved a transfusion reduction response, compared with individual historical transfusion burden standardized to 24 weeks). Twenty two percent of patients were transfusion-free during the fixed-dose period.1 Pyrukynd has launched with an average wholesale price (AWP) of $552 per tablet.

Releuko® (filgrastim-ayow): The FDA approved Amneal’s Releuko as a biosimilar version of Amgen’s Neupogen® (filgrastim). Releuko is indicated to:

  • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever
  • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
  • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)
  • Reduce the incidence and duration of sequelae of severe neutropenia‚ in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia

Releuko was approved on two clinical trials that confirmed pharmacokinetic and bioavailability between Releuko and Neupogen. Releuko has not been granted interchangeable status by the FDA. The FDA noted that biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products. According to IQVIA®, U.S. annual sales for filgrastim for the 12 months ended December 2021 were $407 million, of which $275 million represents biosimilar sales.2 Releuko is the third biosimilar to Neupogen to be approved by the FDA after Sandoz’s Zarxio® (filgrastim-sndz) and Pfizer’s Nivestym® (filgrastim-aafi). Releuko has launched with AWP $273.60 – $437.76 per vial/syringe.

Vonjo® (pacritinib): The FDA granted accelerated approval of CTI BioPharma’s Vonjo for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Vonjo is an oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1. Vonjo was approved based on the Phase 3 PERSIST-2 trial which demonstrated that 29% of patients with baseline platelet counts below 50 × 109/L who were treated with pacritinib 200mg had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy, which included ruxolitinib.3The recommended dosage of Vonjo is 200mg orally twice daily. Vonjo has launched with a wholesale acquisition cost (WAC) of $19,500 per month.

Carvykti® (ciltacabtagene autoleucel; cilta-cel): The FDA approved Legend Biotech Corporation’s Carvykti for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Carvykti is a chimeric antigen receptor T-cell (CAR-T) therapy with two B-cell maturation antigen (BCMA)-targeting single domain antibodies and is given as a one-time infusion with a recommended dose range of 0.5 to 1.0 x 106CAR-positive viable T cells per kg of body weight. In the pivotal CARTITUDE-1 study, deep and durable responses were seen in patients with RRMM, with a high overall response rate (ORR) of 98 percent including 78 percent of the patients achieving stringent complete response (sCR).4 At a median of 18 months follow-up, the median duration of response (DOR) was 21.8 months. Carvykti has launched with a wholesale acquisition cost (WAC) of $465,000.

New Indications

None

March News

“The FDA is staying cautious after data came out suggesting that one of BioMarin’s experimental gene therapies might have the potential to drive cancers. Although details remain sparse, BioMarin said that its gene therapy for the rare disease phenylketonuria, or PKU, will remain on hold after the FDA asked for additional non-clinical — i.e., lab-based or animal studies — to assess “the theoretical oncogenic risk to human study participants.” Those studies, the company said, are “expected to take several quarters.””5

“The adoption of biosimilars tends to accelerate quickly after market introduction, according to Cardinal Health. And their use has grown significantly since 2015. Momentum is “stronger than ever” in the biosimilar space, Cardinal Health’s specialty solutions president Heidi Hunter said. Last year, Viatris’ Semglee became the first interchangeable biosimilar, meaning it can be substituted for the original insulins without a doctor’s input. The drug references Sanfoi’s long-acting insulin, Lantus. Upon launching in November, Viatris said the list price would be set at about $400 for a package of five 3 mL pens, which is about $20 cheaper than the list price for the branded version. The company also simultaneously launched an unbranded version of its insulin glargine product at a 65% list price discount, which the company called “the lowest WAC for any insulin glargine pen on the market to date.” While it’s unclear what 2022 will hold in store for biosimilar pricing and coverage, Cardinal says one message is clear: Momentum in this space is accelerating. Analysts say biosimilars are on track to reduce U.S. drug expenditure by $133 billion by 2025. “2022 is set to be a turning point in the U.S., as biosimilars expand into new therapeutic areas and sites of care, and reimbursement models continue to evolve,” Hunter said.”6

“With two of its prized gene therapies on clinical hold and another, Zynteglo, pulled from the market in Europe seven months ago after it was approved for use, these are not the best of times for bluebird bio. So after updating the status of lovo-cel, eli-cel and beti-cel (Zynteglo) in its fourth quarter and 2021 earnings report, bluebird illuminatedits dire financial situation, saying that its cash needs “raise substantial doubt regarding its ability to continue as a going concern.”7

“Sales of Bristol Myers Squibb’s Revlimid crescendoed at $12.8 billion in 2021, the final year of exclusivity for the multiple myeloma treatment. But now, BMS can no longer hold off generic competition. Last month, Sandoz and Stada Arzneimittel revealed that launches of their generic versions of Revlimid are underway in Europe. Now Teva has become the first to do the same in the U.S. Teva will provide Lenalidomide capsules in 5mg, 10mg, 15mg and 25mg strengths, it said, for the treatment of multiple myeloma in combination with dexamethasone, certain myelodysplastic syndromes and mantle cell lymphoma following specific prior treatment. The company did not note what it would charge.”8

SPECIALTY NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Manufacturer Indication(s) Route of Admin Month Approved
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
levoketoconazole 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
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat StrataGraft™ Mallinckrodt Deep partial-thickness thermal burns Topical June 2021
sofosbuvir/velpatasvir Epclusa® pellets Gilead Hepatitis C Oral June 2021
aducanumab-avwa Aduhelm® Biogen Alzheimer’s disease IV June 2021
plasminogen (human-tvmh) Ryplazim® Prometic Life Sciences Inc Plasminogen deficiency type 1 IV June 2021
pegcetacoplan Empaveli® Apellis Paroxysmal nocturnal hemoglobinuria SC May 2021
NEW INDICATIONS FOR APPROVED SPECIALTY PRODUCTS
Generic Name Brand Name Manufacturer New Indication(s) Date Approved
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 6 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
ravulizumab-cwvz Ultomiris® Alexion Pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH) June 2021
elexacaftor, tezacaftor, and ivacaftor Trikafta® Vertex Pharmaceuticals Ages 6 to 11 with at least one F508del mutation in the CFTR gene (the gene defective in CF) or a CFTR mutation that is responsive to the therapy June 2021
ozanimod Zeposia® Bristol-Myers Squibb Treatment of adults with moderately to severely active ulcerative colitis (UC) May 2021
omalizumab Xolair® Genentech New prefilled syringe for treatment of persistent asthma and chronic idiopathic urticaria April 2021
risankizumab-rzaa Skyrizi® AbbVie New autoinjector and a prefilled syringe with needle stock prevention for treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy April 2021
ONCOLOGY PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Manufacturer Indication(s) Route of Admin Date Approved
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 (TAK-788) 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
asparaginase erwinia chrysanthemi-rywn Rylaze® Jazz Pharmaceuticals Acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) IV June 2021
sotorasib Lumakras® Amgen Certain forms of lung cancer Oral May 2021
infigratinib Truseltiq® QED Therapeutics (BridgeBio) Certain forms of cholangiocarcinoma Oral May 2021
leuprolide mesylate 50 mg depot Camcevi® 42mg Foresee Pharmaceuticals Palliative treatment of advanced prostate cancer Injectable suspension May 2021
amivantamab-vmjw Rybrevant Johnson & Johnson Certain forms of non-small cell lung cancer IV May 2021
dostarlimab-gxly Jemperli™ GlaxoSmithKline (Tesaro) and AnaptysBio Endometrial cancer IV April 2021
loncastuximab tesirine (lonca) Zynlonta™ ADC Therapeutics R/R diffuse large B-cell lymphoma (DLBCL) IV April 2021
NEW INDICATIONS FOR APPROVED ONCOLOGY DRUGS
Generic Name Brand Name Manufacturer New Indication Date Approved
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
evolocumab Repatha® Amgen Add-on treatment to diet alone or together with certain other therapies for patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH) September 2021
cabozantinib Cabometyx® Exelixis and Ipsen Patients aged 12 and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible September 2021
cetuximab Erbitux® Lilly Certain forms of metastatic colorectal cancer (CRC) with a BRAF V600E mutation September 2021
ivosidenib Tibsovo® Agios Pharmaceuticals Locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, which is a rare type of cancer in the bile ducts in the liver September 2021
zanubrutinib Brukinsa® Beigene USA Marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy September 2021
zanubrutinib Brukinsa® Beigene USA Rare indolent B-cell lymphoma Waldenstrom’s Macroglobulinemia (WM) August 2021
nivolumab Opdivo® Bristol-Myers Squibb Certain forms of urothelial carcinoma (UC) August 2021
pembrolizumab Keytruda® Merck First-line treatment of patients with RCC August 2021
pembrolizumab Keytruda® Merck Certain forms of triple negative breast cancer (TNBC) in combination with chemotherapy July 2021
pembrolizumab and lenvatinib Keytruda® and Lenvima® Merck and Eisai Certain forms of advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) July 2021
enfortumab vedotin-ejfy Padcev® Astellas and Seagen Treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and are ineligible for cisplatin July 2021
daratumumab and hyaluronidase-fihj Darzalex Faspro® Janssen Biotech and Genmab Combination regimen with pomalidomide and dexamethasone (d-Pd) for treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy July 2021
avapritinib Ayvakit® Blueprint Medicines Corp Adults with advanced systemic mastocytosis (SM) June 2021
pembrolizumab Keytruda® Merck Certain combination for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma May 2021
nivolumab Opdivo® Bristol-Myers Squibb Adjuvant treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer after neoadjuvant chemoradiation therapy (CRT) May 2021
nivolumab Opdivo® Bristol-Myers Squibb Certain forms of advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC) May 2021
lorlatinib Lorbrena® Pfizer Treatment of previously untreated advanced ALK-positive non-small cell lung cancer (NSCLC) April 2021
sacituzumab govitecan-hziy Trodelvy® Gilead Sciences Triple-negative breast cancer that has spread to other parts of the body April 2021
nivolumab Opdivo® Bristol-Myers Squibb Initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma April 2021
BIOSIMILAR PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Reference

Product

Manufacturer Indication(s) Route of Admin Month Approved
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® biosimilar Coherus Autoimmune SC December 2021
ranibizumab-nuna Byooviz Lucentis® biosimilar Samsung Bioepis Age related macular degeneration Intravitreal September 2021
insulin glargine-yfgn

First interchangeable 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*
CPP-1X/sul (eflornithine and sulindac) N/A 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
bimekizumab Bimzelx® UCB Pharma Psoriasis SC Delayed
inolimomab Leukotac® Farmaceutici Spa Steroid-refractory acute graft-versus-host disease IV Delayed
penpulimab (AK105) N/A Akeso and Sino Biopharmaceutical Metastatic nasopharyngeal carcinoma IV Delayed
sintilimab N/A Innovent Biologics and Lilly Nonsquamous non-small cell lung cancer (NSCLC) IV March 2022
relatlimab and nivolumab N/A Bristol Myers Squibb Certain forms of metastatic melanoma IV March 2022
ganaxolone Ztalmy™ Marinus Pharmaceuticals, Inc. Seizures associated with CDKL5 deficiency disorder (CDD) Oral March 2022
vadadustat Vafseo™ Akebia Therapeutics Anemia due to chronic kidney disease (CKD) Oral March 2022
efbemalenograstim alfa Ryzneuta™ Evive Biotech Chemotherapy-induced neutropenia SC March 2022
toripalimab Tyoyi™ Junshi Biosciences and Coherus Certain forms of recurrent or metastatic nasopharyngeal carcinoma IV April 2022
vutrisiran N/A Alnylam Pharmaceuticals Polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis SC April 2022
mavacamten N/A Bristol-Myers Squibb Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) Oral April 2022
surufatinib N/A Hutchmed Pancreatic and extra-pancreatic neuroendocrine tumor Oral April 2022
parsaclisib N/A Incyte Certain forms of mantle cell lymphoma (MCL) Oral April 2022
edaravone, oral N/A Mitsubishi Tanabe Pharma Amyotrophic lateral sclerosis (ALS) Oral May 2022
trientine tetrahydrochloride Cuprior™ Orphalan Wilson’s disease Oral May 2022
tapinarof N/A Dermavant (Roivant) Plaque psoriasis Topical May 2022
miglustat (for AT-GAA combination with cipaglucosidase alfa) N/A Amicus Therapeutics Pompe disease Oral May 2022
ublituximab N/A TG Therapeutics Certain forms of chronic lymphocytic leukemia (CLL) IV June 2022
spesolimab N/A Boehringer Ingelheim Generalized pustular psoriasis (GPP) flares IV June 2022
sodium phenylbutyrate and taurursodiol N/A Amylyx Pharmaceuticals, Inc. Amyotrophic lateral sclerosis (ALS) Oral 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
roflumilast cream (ARQ-151) N/A Arcutis Biotherapeutics, Inc. Plaque psoriasis Topical July 2022
cipaglucosidase alfa* (in combination with miglustat) N/A Amicus Therapeutics Pompe disease IV July 2022
olipudase alfa N/A Sanofi (Genzyme) Niemann-Pick disease IV July 2022
parsaclisib N/A Incyte Certain forms of follicular lymphoma (FL) Oral August 2022
teplizumab Tzield™ Provention Bio Diabetes IV August 2022
deucravacitinib N/A Bristol Myers Squibb Plaque psoriasis Oral September 2022
ublituximab N/A TG Therapeutics Relapsing multiple sclerosis IV September 2022
poziotinib N/A Spectrum Pharmaceuticals, Inc. Certain forms of metastatic non-small cell lung cancer (NSCLC) Oral November 2022
adagrasib N/A Mirati Therapeutics Second-line treatment of advanced non-small cell lung cancer (NSCLC) Oral December 2022

* Anticipated approval dates are predictions made by Prime Therapeutics based on industry information.

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
BEVZ92 N/A (Avastin® biosimilar) mAbxience, Insud Pharma; Amneal 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
TPI-120 N/A (Neulasta® biosimilar) Amneal and Kashiv (Adello) 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
TX-01 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
MYL-1701P N/A (Eylea® biosimilar) Mylan Age-related macular degeneration Injection into the eye 2022
Autoimmune
AVT02 N/A (Humira® biosimilar) Alvotech Autoimmune SC 2022
CT-P17 Yuflyma® (Humira® biosimilar) Celltrion Autoimmune SC 2022
adalimumab-bwwd (SB5 100mg/mL) N/A (Humira® biosimilar) Samsung Bioepis and Organon Autoimmune SC 2022
FDA APPROVED GENE/CELL THERAPY PRODUCT APPROVALS
Generic Name Brand Name Manufacturer Indication(s) Route of Admin Month Approved
ciltacabtagene autoleucel (cilta-cel) Carvykti™ Johnson & Johnson (Janssen) R/R multiple myeloma CAR-T February 2022
allogeneic processed thymus tissue adgc Rethymic™ Enzyvant Congenital athymia Surgical October 2021
idecabtagene vicleucel (bb2121, ide-cel) Abecma™ Bristol-Myers Squibb and bluebird bio Multiple myeloma CAR-T March 2021
lisocabtagene maraleucel

(liso-cel)

Breyanzi™ Bristol-Myers Squibb Large B cell lymphoma (LBCL) IV February 2021
brexucabtagene autoleucel Tecartus™ Kite Mantle cell lymphoma CAR T-cell therapy July 2020
onasemnogene abeparvovec-xioi Zolgensma AveXis Spinal Muscular Atrophy IV May 2019
voretigene neparvovec-rzyl Luxturna® Spark Therapeutics Biallelic RPE65 mutation-associated retinal dystrophy Subretinal injection December 2017
axicabtagene ciloleucel Yescarta® Kite LBCL/follicular lymphoma (FL) IV October 2017
tisagenlecleucel Kymriah® Novartis Acute lymphoblastic leukemia/LBCL IV August 2017
GENE/CELL THERAPY 2022 PIPELINE
Generic Name Brand Name Manufacturer Indication(s) Route of Admin Anticipated Approval date*
betibeglogene autotemcel N/A Bluebird Bio Transfusion-dependent beta-thalassemia (TDT) IV  August 2022
elivaldogene autotemcel Lenti-D™ Bluebird Bio Cerebral adrenoleukodystrophy (CALD) IV September 2022
etranacogene dezaparvovec EtranaDez™ CSL Behring Hemophilia B IV 3Q2022
valoctocogene roxaparvovec Roctavian™ BioMarin Hemophilia A IV 4Q2022
eladocagene exuparvovec PTC-AADC PTC Therapeutics Aromatic L-amino acid decarboxylase (AADC) deficiency Intracerebral 4Q2022

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