• Regulatory NewsRegulatory News

    FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

    The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product. The efforts are part of FDA’s decade-long work to begin, starting in March 2020, transitioning the approved...
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    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About Biosimilars

    For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption. What is a Biosimilar? A biosimilar medicine (also sometimes k...
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    BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years

    Rep. Jan Schakowsky (D-IL) and three Democratic colleagues in the House took a jab at the biotech industry on Thursday, introducing a new bill that would reduce the amount of exclusivity for biologics from 12 years to seven years. The introduction of the politicized bill comes as President Barack Obama has been pushing to lower the exclusivity threshold since at least 2010, though none of those plans have materialized. However, Obama also supports the Trans-Pacific Partn...
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    Updated: Biosimilars in the US: Panel Discusses Tricky Balance of Building the Market With Necessary Precautions

    Biosimilar experts, including the US Food and Drug Administration's (FDA) Dr. Leah Christl and biosimilar developer Coherus Biosciences' chief medical officer Dr. Barbara Finck, sat down on Monday at an Alliance for Health Reform event to discuss the challenges the US faces in developing a robust biosimilars market and also ways the US can avoid fear mongering and increase uptake. Coherus' Finck, who was the only member of the panel with actual experience developing bios...
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    Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA

    Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the  Biologics Price Competition and Innovation Act  (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period. The provision in the BPCIA in question states that: "An approved application for a ...
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    FDA Offers New Guidance on Interpretation of BPCIA

    The US Food and Drug Administration (FDA) on Friday released draft guidance on its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010. Put simply: FDA will not approve any pending or tentatively approved application for a biological product under the Federal Food, Drug, and Cosmetic (FD&C) Act after 23 March 2020.  The provision in the BPCIA states that: "An approved application for a biologi...
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    Woodcock: FDA Needs More Funds for Biosimilar Review Program

    Shuttling back and forth between two different House committee hearings on Thursday, US Food and Drug Administration’s (FDA) CDER Director Janet Woodcock made clear in a later hearing on biosimilars that the agency needs Congressional appropriations to properly run its biosimilar review program. When the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010, FDA received no additional congressional appropriations to run the program, Woodcock said, fo...