Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
The Seventh Circuit recently confirmed that Actavis is the appropriate framework to assess biosimilar patent settlements, despite the differences in the regulatory structure—the first appellate court ruling on this issue. In...more
For nearly a decade, the Supreme Court’s FTC v. Actavis decision has guided pharmaceutical litigators and advisors exploring the antitrust risks inherent in settling pharmaceutical patent lawsuits, especially when such...more
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...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
Last week the 7th Circuit Court of Appeals heard arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal concerns the United States District Court for the Northern District of Illinois’...more
In a recent decision in In Re Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873, Judge Shah of the Northern District of Illinois dismissed a consolidated class action complaint filed by U.S. purchasers of AbbVie Inc.’s...more
On March 9, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), will host a public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” ...more
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices...more
The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release,...more
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological...more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more
On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more
The summer of 2018 has brought a renewed focus on the U.S. biosimilars market. The market to date has been, in the words of FDA Commissioner Scott Gottlieb, “anemic”: there are only 4 biosimilars on the U.S. market, and they...more
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for...more
The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more