Biosimilars, or “generic biologics,” are rapidly emerging as the next frontier in the expansive pharmaceuticals industry. Polsinelli’s Biologics team is at the forefront in this field, ready to assist at every step in the complex process of obtaining approval for biosimilar drugs. The emerging Biologics License Application (BLA) pathway created by the Biologics Price Competition and Innovation Act (BPCIA) established the process for a company to seek and obtain approval for a biosimilar. As the bounds of this process have continued to take shape the past several years, our attorneys have counseled some of the world’s largest, best-known, and most influential generic, brand, and specialty pharmaceutical companies regarding the regulatory and legal issues associated with the process and BLA applications.

The BPCIA, while similar in some general respects to the Hatch-Waxman Act process for obtaining generic approval of small molecule pharmaceuticals, differs in important ways. Our team combines collective decades of experience advising clients regarding generic drugs under the Hatch-Waxman Act, with a deep bench of highly skilled and experienced professionals holding advanced degrees in the biologic fields, including molecular biology, biochemistry, chemistry, organic chemistry, microbiology, genetics, immunology, microbial pathogenesis, neuroscience, and pharmacology. Our team monitors all BLA filings and developments related to the BLA process, as well as the legal and policy developments in this rapidly-evolving area. We provide patent landscape opinions, due diligence reviews, and pre-litigation strategy in advance of the so-called BPCIA “patent dance,” and stand prepared to guide clients through litigation to obtain FDA approval of biosimilars.
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June 24-25, 2019
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Q. Todd Dickinson to Moderate and Timothy A. Worrall to Speak on Panel at the 2019 BIO International Convention in Philadelphia, Pennsylvania
June 3-6, 2019
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Milan M. Vinnola and Rhiannon I. D’Agostin to Speak at ACI 9th Annual Summit on Biosimilars in New York, New York
June 25-27, 2018
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February 2018
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Timothy A. Worrall, Ph.D. and David W. Clough, Ph.D. to Speak at 3rd Annual Biosimilars Market Access & Commercialization Summit in Philadelphia, Pennsylvania
February 5-7, 2018
eAlerts Updates
December 2017
eAlerts Updates
December 2017
eAlerts Updates
June 2017
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Timothy A. Worrall, Ph.D. and Tara A. Nealey, Ph.D. to Speak at ACI 8th Annual Summit on Biosimilars in New York, New York
June 12-14, 2017
eAlerts Updates
July 8, 2016