Policy

Last week’s ruling in the federal circuit, which held that state law cannot compel biosimilar applicants to participate in the Biologics Price Competition and Innovation Act (BPCIA) “patent dance,” has raised questions about how the case will impact the BPCIA in the days ahead. Yet Kevin M. Nelson, JD, partner at Schiff Hardin’s Hatch-Waxman and biosimilars practice, told The Center for Biosimilars® in an interview, that, “For the BPCIA, I don’t think it means much.” In Nelson’s view, the most significant impact that the ruling will have is on the early case assessments that biosimilar applicants undertake when determining whether they will take part in the information exchange process.

Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus.

The way clinical trials are conducted and reported in the European Union will undergo a major change when the Clinical Trial Regulation comes into force in 2019.

The Center for Biosimilars® recaps the top 5 articles for the week of December 11.

Hospitals classified as 340B institutions are playing an increasingly large role in oncology care, and the rapid growth in the federal 340B program has resulted in big changes in the oncology drug marketplace, according to a recent white paper released by the Community Oncology Alliance.

Mark Fendrick, MD, discusses the role that biosimilars will play in value-based insurance design (VBID).

The federal circuit ruled today in Amgen v Sandoz that state law cannot compel drug makers to participate in the so-called “patent dance” provided for in the Biologics Price Competition and Innovation Act because state law cannot preempt federal law.

On December 13, the House of Representatives Committee on Energy and Commerce’s Subcommittee on Health heard testimony from a variety of healthcare stakeholders in a hearing titled “Examining the Drug Supply Chain.” During the proceeding, a follow-up to a hearing on implementation of the 21st Century Cures Act, several witnesses focused their attention on the promise of—and challenges specific to—biosimilars in the US marketplace.

A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed.

The pharmaceutical industry trade and lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) sued California state officials in federal court on December 8, 2017, over California’s new drug pricing law, which the group states is “unprecedented and unconstitutional.”

While the American College of Rheumatology praised the FDA for considering ways to reduce regulatory burden, the organization called on the FDA to focus on 6 “minimum components of review and oversight” for biosimilars.

The Center for Biosimilars recaps the top 5 articles for the week of December 4.

Advances in research have led to increased therapeutic options for patients with cancer, but these drugs come at a substantial cost; high out-of-pocket costs pose a significant barrier to treatment initiation for patients with cancer, according to a new, retrospective claims-based study.

A new report from calls for big changes in how US pharmaceuticals are priced, promoted, and sold so that treatments are more affordable and equally available to all Americans, as market mechanisms that would usually moderate prices have been blunted or eliminated.

The Association for Accessible Medicines (AAM), a trade association that represents biosimilar and generic drug makers, has filed an amicus brief in support of Mylan, Teva, and Akorn in their inter partes review (IPR) proceeding against Allergan, owner of embattled patents covering cyclosporine ophthalmic emulsion (Restasis).

Yesterday, community oncology leaders flooded the Hill to meet with Congress and the administration to warn them of the impact the Medicare sequester’s increased cuts and extension will have on cancer care nationwide.

The Center for Biosimilars recaps the top 5 articles for the week of November 27.

November saw a number of developments related to biosimilar therapies for rheumatologic indications, with new data published, policies adapted, and devices launched.

HHS has rescinded its approval of a major charity, Caring Voice Coalition, after the charity allowed pharma donors improper influence over the nonprofit.

Angus Worthing, MD, FACR, FACP, describes policy changes that are needed in the biosimilars space.

The European Commission (EC) has launched a patient-focused question-and-answer document, titled “What I Need to Know About Biosimilar Medicines,” in 23 EU languages.

A recent report by the World Health Organization (WHO) showed that nearly 1 in every 10 drugs is falsified or substandard, and estimates the net worth of the industry for such drugs at nearly $30 billion.

This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR) is constitutional.

Health Canada looks to lower the maximum price for drugs, but doing so could delay patient access, warns Montreal Economic Institute.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of November 20.

The United Kingdom's National Institute for Health Research (NIHR), part of the National Health Service (NHS), has created a website to educate the public about biosimilar drugs.

Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses major regulatory and policy differences between the European Union and the United States.

Results of a new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) shows that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars,

The American College of Rheumatology (ACR) has voiced its approval of CMS’ attempts to lower the cost of drugs under Medicare Part D, but also called on the organization to allow more rheumatologists, including those in small practices, to take part in alternative payment models (APMs).

Amsterdam, Netherlands, has won its bid to become the new home of the European Medicines Agency.