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2. Biological therapy for inflammatory bowel disease - Wikipedia

   en.wikipedia.org/wiki/Biological_therapy_for...

   Instead there are biosimilars. Biosimilars are defined by the FDA as, "a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product." [28] Currently, the only two biologic treatments for IBD that have approved biosimilars are adalimumab and infliximab. [11]

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

   www.aol.com/news/us-fda-proposes-remove...

   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 ...

4. Infliximab - Wikipedia

   en.wikipedia.org/wiki/Infliximab

   Infliximab was approved for medical use in the United States in 1998, [23] and in the European Union in August 1999. [19] Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United States (2016, 2017, 2019). [1] [4] [2] It is on the World Health Organization's List of Essential Medicines. [25]

5. Biological response modifier - Wikipedia

   en.wikipedia.org/wiki/Biological_response_modifier

   Biosimilar is a term used to describe a biopharmaceutical product which seems so close in composition and effect to another that they are functionally identical, analogous to generic drugs. In this context, some publications describe "biologics" as "biosimilars". [26]

6. 3 Big Battles in Biosimilars to Watch - AOL

   www.aol.com/2014/03/05/3-big-battles-in...

   The global market for biosimilars, or generic versions of biologic medical products, is expected to soar to $24 billion by 2019, according to a recent report from Frost & Sullivan -- not bad for a ...

7. Johnson & Johnson (JNJ) Q4 2024 Earnings Call Transcript - AOL

   www.aol.com/johnson-johnson-jnj-q4-2024...

   Despite Stelara biosimilar competition and the impact of Part D redesign, we expect our 2025 adjusted pre-tax operating margins to increase by approximately 300 basis points, of which ...