LexBlog IP

NOVEMBER 22, 2021

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products.

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Fish & Richardson Trademark & Copyright Thoughts

MARCH 8, 2021

This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors review FDA’s preparation for the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic.

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Bio Law Blog

FEBRUARY 2, 2020

Buried in a 2020 spending bill passed in December 2019 is a provision that amends the definition of “Biological Product” in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and thereby expands the products that will be regulated as biologic medicines and litigated under the BPCIA.

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Fish & Richardson Trademark & Copyright Thoughts

FEBRUARY 4, 2021

The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since 2016 and fewer product launches than 2019—as well as a decrease in district court litigation and post-grant proceedings.

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Bio Law Blog

JANUARY 8, 2020

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. 2020 will also usher in some notable changes expanding the scope of products that are regulated and litigated under the BPCIA. This year, the BPCIA turns 10.

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Fish & Richardson Trademark & Copyright Thoughts

JANUARY 11, 2022

Yet, given fewer FDA approvals in 2020 and 2021, this year saw the lowest number of commercial launches since 2017. Litigation under the Biologics Price Competition and Innovation Act (BPCIA) in the district courts also decreased. Legislation and Executive Orders Relating to Biologics and Biosimilars. August 31, 2020.

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