Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
On November 6, 2025, Amgen filed its eighth and ninth BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-17277 (D.N.J.) against Alvotech and Dr. Reddy’s AVT03 and Case No....more
The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative analytical assessments (CAA)...more
On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), announced a new strategy aimed...more
It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general inclination is true of the Department of Health and Human Services and the agencies...more
Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late...more
The US Court of Appeals for the Seventh Circuit affirmed that welfare benefit plans that bought the drug Humira did not have valid antitrust claims against the patent owner. The Court found that amassing patents by itself is...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
On Aug. 23, 2021, the U.S. District Court for the Northern District of Illinois denied Alvotech hf.’s motion to dismiss AbbVie’s biosimilar lawsuit involving its blockbuster arthritis drug, Humira. AbbVie Inc. et al. v....more
Biologics are revolutionizing the pharmaceutical industry, and in doing so, garnering an increasing share of antitrust attention. In recent years, the FTC, FDA, and antitrust plaintiffs’ bar have raised concerns about a...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. This past quarter as COVID spread across the globe, challenges to patents...more
As we close out another calendar year, we look back at the top legal developments of 2020 that could influence the market for biologics and biosimilars. While there were a number of case-specific decisions this past year...more
PATENT CASE OF THE WEEK - Immunex Corp. v. Sandoz Inc., Appeal No. 2020-1037 (Fed. Cir. July 1, 2020) - In this Biologics Price Competition and Innovation Act case, the Federal Circuit affirmed the bench trial ruling of...more
U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more
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. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more
More than two years ago, on January 17, 2017, the U.S. Food and Drug Administration released its Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation...more
Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more
On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and adults with biallelic REP65 mutation-associated retinal dystrophy, an inherited...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more
In a unanimous decision, the United States Supreme Court has clarified certain portions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), concluding (1) that biosimilar makers do not have to wait for...more