Policy

IGBA's Trade Principles Address Regulatory Convergence and Intellectual Property Concerns

August 7th 2019

By The Center for Biosimilars Staff

The International Generic and Biosimilars Medicines Association (IGBA), which represents generic and biosimilar medicines associations worldwide, recently released its report on how trade agreements can foster generic and biosimilar medicines and improve patient access to care.

Paper Proposes Methodology to "Protect Health Systems" That Use Biosimilars

August 7th 2019

By Kelly Davio

Article

A study published this month proposes that biosimilars be assessed in a quantitative benefit-risk analysis to assess whether what the authors call “uncertainty in the clinical performance of biosimilars” can be countered by lower pricing.

Are Authorized Biologics Poised to Hold Back Biosimilars?

August 6th 2019

By Kelly Davio

Article

Not everyone shares the view that authorized generics are a boon, and concerns are rising that the marketplace may soon see the advent of authorized biologics.

Nudging Biosimilars Closer to Fulfilling Their Promise in the United States

August 2nd 2019

By Allison Inserro

Article

Will biosimilars improve public health? Policy makers should look to that question as they sort through possible solutions, the authors say.

Debate Over Whether Biologics Constitute Natural Monopolies Continues

August 1st 2019

By Allison Inserro

Article

“We wish biosimilar competition would efficiently lower biologics prices to the socially optimal level of marginal economic cost,” wrote Bach and coauthors. “But, in this case, the ideological preference for competition needs to be put aside for a more effective, efficient, and economically justified approach of regulating biologics as natural monopolies.”

Brand-to-Brand Competition Does Not Reduce Drug Prices, Review Says

August 1st 2019

By Kelly Davio

Article

A study published this week in PLoS Medicine suggests that brand-to-brand competition is not likely to reduce drugs’ list prices.

Bipartisan House Bill Seeks to Amend Patent Dance With Limit on Some Types of Patents

August 1st 2019

By Allison Inserro

Article

The chairman and the ranking member of the Judiciary Subcommittee on Courts, Intellectual Property and the Internet in the House of Representatives, proposed a bipartisan bill to amend the patent dance in the Biologics Price Competition and Innovation Act (BPCIA) by capping the number of some types of patents that may be claimed by the maker of the reference product.

HHS Announces Plan to Allow Importation of Foreign Drugs, Potentially Including Insulin

July 31st 2019

By The Center for Biosimilars Staff

Article

The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking to authorize importation of drugs from Canada. The second pathway would allow manufacturers to import versions of FDA-approved drugs that are sold in other countries.

Conservative Thinkers Share Their Views for Biosimilars in a Post-ACA, BPCIA Landscape

July 24th 2019

By Allison Inserro

Article

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

Court Calls Genentech's Actions In Trastuzumab Case "Contrary to the Spirit" of the BPCIA

July 24th 2019

By Kelly Davio

Article

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.