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2. Novartis' Sandoz wagers its standalone future on biosimilar ...

   www.aol.com/news/novartis-sees-sandoz-adding-3...

   Novartis' soon-to-be spun off generics division Sandoz is betting on biosimilars, copies of high-priced drugs used to treat illnesses such as rheumatoid arthritis and cancer, to fuel its future as ...

3. Biosimilar - Wikipedia

   en.wikipedia.org/wiki/Biosimilar

   The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz.

4. US FDA proposes to remove switching study requirement for ...

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   The FDA has generally recommended switching studies to show evidence of interchangeability of a biosimilar. Regulatory reform is needed so patients can more easily access biosimilars and draw ...

5. Novartis' Sandoz targets biosimilar version of J&J drug in ...

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   Samsung Bioepis' clinical development programme for the Stelara biosimilar is well-advanced and Sandoz secured the rights to commercialize the product in the United States, Canada and most of ...

6. Drug Price Competition and Patent Term Restoration Act

   en.wikipedia.org/wiki/Drug_Price_Competition_and...

   An Act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes. Acronyms (colloquial) Hatch-Waxman amendments: Enacted by: the 98th United States Congress: Effective

7. Biologics Price Competition and Innovation Act of 2009

   en.wikipedia.org/wiki/Biologics_Price...

   The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.

8. US FDA approves Amgen's biosimilar to AstraZeneca's rare ...

   www.aol.com/news/us-fda-approves-amgens...

   Biosimilars are close copies of complex biological drugs. In 2022, the company said that Bkemv met the main goal of a late stage study, where the safety and immunogenicity of the drug was ...

9. Association for Accessible Medicines - Wikipedia

   en.wikipedia.org/wiki/Association_for_Accessible...

   As the primary lobby for makers of generic drugs, [1] AAM's stated mission is to advocate for public policies that facilitate timely access to lower-cost, FDA-approved generic and biosimilar medicines by consumers and patients. Over the 10-year period 2008 through 2018, the use of generic drugs generated $2 trillion in U.S. healthcare savings.