Biosimilar Development News

1. Mylan And Lupin Receive European Marketing Authorization For Nepexto®, Biosimilar Etanercept 6/4/2020

   Mylan N.V. (NASDAQ: MYL) and Lupin Limited (Lupin) today announced that the European Commission (EC) has granted marketing authorization for Nepexto®, a biosimilar to Enbrel® (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.

2. Henlius And Accord Receive Positive CHMP Opinion For Oncology Biosimilar, HLX02 (Trastuzumab) 6/1/2020

   Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for biosimilar HLX02 (trastuzumab for injection), for the treatment of HER2 positive early breast cancer, HER2 positive metastatic breast cancer and previously untreated HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction.

3. Revance And Mylan To Advance Development Program For Biosimilar To BOTOX 6/1/2020

   Revance Therapeutics, Inc. and Mylan N.V. today announced Mylan’s decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX and BOTOX Cosmetic (onabotulinumtoxinA), the market-leading neuromodulator.

4. Innovent Biologics Announced The Results Of The Phase 1b Clinical Study Of TYVYT® (Sintilimab Injection) In Combination With IBI305 (Bevacizumab Biosimilar) In The Treatment Of Advanced Hepatocellular Carcinoma 5/31/2020

   Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, announced the Phase 1b preliminary clinical study (NCT04072679) data of TYVYT® (sintilimab injection) in combination with IBI305, a bevacizumab biosimilar independently developed by Innovent, in the treatment of advanced hepatocellular carcinoma at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO)(Abstract # 3079, Poster # 143, 8:00 AM – 11:00 AM, U.S. Central Time, Friday, May 29, 2020).

5. New Data Show First-Line Triplet Regimen Of Pembrolizumab, Herzuma (Biosimilar trastuzumab) And Chemotherapy Are Effective In Treatment Of HER2-Positive Advanced Gastric Cancer 5/28/2020

   Data presented today as part of the ASCO20 Virtual Scientific Program show that a first-line triplet regimen comprising of pembrolizumab, Herzuma (biosimilar trastuzumab) and chemotherapy is effective in patients with HER2-positive advanced gastric cancer (AGC).

6. Fresenius Kabi Enters Marketing Agreement For Biosimilar Product 5/28/2020

   Fresenius Kabi and the pharmaceutical company medac have agreed to cooperate in Germany in the area of treatments for rheumatic illnesses. On June 1, medac’s sales representatives will begin offering the adalimumab biosimilar IDACIO as an additional therapy option to the rheumatologists and dermatologists they work with.

7. Bringing Down Federal Spending: A Biosimilars Shared Savings Model To Lower Health Care Costs 5/28/2020

   Biologics, life-changing treatment options for patients with diseases like cancer, Crohn’s disease, and rheumatoid arthritis, accounted for 42% of the $344B U.S.

8. Robust Biosimilars Market Could Save U.S. Taxpayers $7B Annually, New Analysis Finds 5/28/2020

   U.S. taxpayers and the health care system at-large could save up to $7B annually with a stronger, more competitive biosimilars market, a substantial increase from the current annual cost-savings of $240.4M, according to a new analysis.

9. FDA Accepts For Review Fresenius Kabi’s BLA Submission For Pegfilgrastim Biosimilar 5/27/2020

   Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, announced today the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for MSB11455, the company’s pegfilgrastim biosimilar candidate for Neulasta

10. Henlius Received IND Approval For Denosumab Biosimilar HLX14 From NMPA 5/27/2020

    Shanghai Henlius Biotech, Inc. (2696.HK) announced that an investigational new drug (IND) application has been approved by the National Medical Products Administration (NMPA) of HLX14, a recombinant anti-RANKL fully human monoclonal antibody injection, for the treatment of postmenopausal women with osteoporosis at high risk for fracture. HLX14 is a Denosumab biosimilar independently developed by Henlius.