Biosimilar Development News

1. Mylan And Lupin Announce Positive CHMP Opinion For Nepexto®, Biosimilar Etanercept 3/27/2020

   Mylan N.V. (NASDAQ: MYL) and Lupin Limited (Lupin) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of 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. IGBA Urgent Recommendations To Keep Medicine Supply Chains Flowing 3/27/2020

   The current operating model of medicines supply requires transparent global collaboration to provide access to medicines for patients around the world. IGBA firmly believes that any restrictions on the export of pharmaceutical products are counterproductive in responding to a global public health crisis.

3. iBio Supporting AzarGen Biotechnologies’ Development Of A Rituximab Biosimilar 3/26/2020

   iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”) today announced that it has entered into a second Statement of Work under its Master Joint Development Agreement (the “MJDA”) with AzarGen Biotechnologies (Pty.) Ltd. (“AzarGen”). Signed in 2018, the MJDA contemplates initial contract development and manufacturing of AzarGen’s biosimilars at iBio’s Bryan, Texas facility

4. Samsung Bioepis Announces FDA Approval Of 420 mg Multi-Dose Vial Of ONTRUZANT (trastuzumab-dttb) 3/24/2020

   Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® i (trastuzumab).

5. Alvotech And DKSH Partner To Bring Key Biosimilar To Asia 3/24/2020

   Alvotech Hf and DKSH, a leading healthcare provider across 36 emerging countries in South-East Asia, today announced that Alvotech Hf and DKSH have entered into an exclusive license partnership for the commercialization of AVT02, an adalimumab biosimilar, in selected APAC markets.

6. Insulin Gains New Pathway To Increased Competition 3/23/2020

   Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.

7. Brighter’s Main Actiste Patent Granted In India – Can Support The Growing Biosimilar Industry 3/19/2020

   Brighter's main patent for Actiste has been granted in India, a front-running market in the biosimilar industry

8. Teva And Celltrion Healthcare Announce U.S. Availability Of HERZUMA (trastuzumab-pkrb) For Injection 3/16/2020

   Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare, Co., Ltd., today announced that HERZUMA1 (trastuzumab-pkrb) for Injection, a biosimilar to HERCEPTIN1, is now available in the United States with the same indications as the reference product including:

9. The Biosimilars Forum Applauds Senators McSally (R-AZ) And Jones (D-AL) Introduction Of S. 3466, The ACCESS For Biosimilars Act Of 2020 3/13/2020

   This legislation is a critical step toward reinforcing the sluggish biosimilars market in the U.S., while also directly helping patients save money. Congress continues to recognize that the savings potential of biosimilars is the right thing to do for patients, taxpayers, and the health care system at-large.

10. ICYMI: This Week, HHS Secretary Azar, Congressman Burgess, Physicians And Patients Pointed To Biosimilars To Save Seniors And Taxpayers Money; Congress Introduces Two Bills To Lower Costs With Biosimilars 3/13/2020

    The Biosimilars Forum and Hatch Center Foundation co-hosted a Symposium on Tuesday, March 10: Breaking through the Barriers, featuring patients, physicians, policymakers and a keynote by HHS Secretary Alex M. Azar II.