Regulatory

There’s not enough study of the effects of international reference pricing, but it is likely to stifle innovation and create access problems, according to an expert panel at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

Although India is far ahead of other countries in terms of biosimilar approvals, its regulatory structure may hinder efforts for international sales.

India entered the biosimilar market early and has nearly 100 approved biosimilars, but experts say its regulatory system is not considered world-class, which may hinder international marketing of these products.

Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies.

Ted Mathias and Stacie Ropka, PhD, patent attorneys and partners at Axinn, Veltrop, and Harkrider LLP, discuss past and future court decisions that leave the Affordable Care Act (ACA) in jeopardy and what could happen to the Biologics Price Competition and Innovation Act (BPCIA) as a result.

Ted Mathias and Stacie Ropka, PhD, patent attorneys and partners at Axinn, Veltrop, and Harkrider LLP, discuss the overall pushback to the Affordable Care Act (ACA) and what that means for the Biologics Price Competition and Innovation Act (BPCIA).

The Committee for Medicinal Products for Human Use (CHMP) has given its recommendation for the marketing authorization of Insulin aspart Sanofi.

Taking an abundance of time to file a motion to block Kanjinti from coming to market, Genentech unwittingly may have tipped the scales in favor of biosimilar applicants.

Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.

A peer-reviewed study suggested that comparative efficacy trials are not always needed to determine efficacy equivalence for biosimilars, as data from pharmacokinetic (PK) studies and in vitro functional assays may suffice.

The Center for Biosimilars® recaps the top stories for the week of March 30, 2020.

Matt Harman talks about employer interest in biosimilar promotion and how the FDA's new biologics pathway change will affect interest levels, during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Wayne Winegarden, PhD, talked about the issues and benefits of the FDA's switch to a biologics regulatory pathway for certain products, especially insulin, during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Sheila Frame, the vice president of marketing, market access, and patient services at Sandoz, discusses US biosimilar policies in development and the impact they will have on the market at the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California.

The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.

In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.

The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.

The FDA announced changes or updates to several policies. Chief among them: final guidance on a regulatory shift for insulin and certain other products.

The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.

Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.

The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.

The Office of Pharmaceutical Quality, charged with strengthening and building public trust in the US supply of medicine, notes that March 23, 2020, will mark a key turning point in the way that many biologics are licensed.

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.

The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.