Policy

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 1, 2018.

AbbVie is increasing Humira's price by 9.7%. That price increase could add $1.2 billion to the US healthcare system’s drug costs in 2018, according to one analyst.

On January 2, counsel for the Saint Regis Mohawk Tribe filed a motion for discovery and requested an oral hearing concerning which judges will sit on the Patent Trial and Appeal Board (PTAB) panel that oversees its case.

Can lower cost biosimilars create a policy solution for seniors enrolled in the Medicare Coverage Gap Discount Program?

The Center for Biosimilars recaps the most-read articles of 2017.

Elan Rubinstein, PharmD, MPH, voiced his frustration with the lack of presence the pharmacy profession has had in the negotiations of repealing and replacing the Affordable Care Act.

The Center for Biosimilars recounts 4 of the top legal developments in the biosimilars space during 2017.

Biosimilar drugs significantly influence the reimbursement systems of 10 Central and Eastern European countries, and the expenditure on the reimbursement of biosimilars (percentage of drug price covered by public payers) in those countries is increasing as biosimilars become more accessible to patients.

2017 brought a number of notable guests to The Center for Biosimilars®. Here are the most-watched interviews of the year.

The Center for Biosimilars recaps the the top 5 articles for the week of December 18, 2017.

The US Government Accountability Office (GAO) reports that retail drug spending accounted for about 12% of total personal healthcare service spending in the United States in 2015, up from about 7% through the 1990s.

Developments at the FDA and greater physician acceptance of biosimilars made 2017 a banner year for emerging therapies, according to James Stevenson, PharmD, FASHP, professor of clinical pharmacy at the University of Michigan College of Pharmacy.

On December 19, Richard Seeborg, US district judge for the Northern District of California, granted a summary judgment of noninfringement in Amgen v Sandoz.

Tax disclosure forms for 2016 show that the pharmaceutical industry’s biggest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), raised revenue by almost one-fourth and spent the millions collected among hundreds of lobbyists, politicians, and patient groups—the largest income surge reported by the group since 2009, when it was mobilizing forces to advance the industry’s interests prior to the passage of the Affordable Care Act.

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).