Regulatory

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discussed the new pathway for insulin biosimilars and the struggles between payers and providers over biosimilar choice.

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discusses potential legislation that the AAM is advocating for and how the upcoming election and Supreme Court decision will affect biosimilars.

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

Although biosimilar uptake has been slow in the United States, the current administration has enacted several policies to help speed up the process, according to Michael Kolodziej, MD, who presented at the National Comprehensive Cancer Network (NCCN) 2020 Virtual Conference.

In July 2020 Canada will implement a series of reforms to help bring runaway drug prices under control, panelists said at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

Real world evidence (RWE) was cited differently depending on a number of criteria, leaving the door open to future research on how RWE influences payer decision making for specialty drug plans, said presenting author, Ari Panzer, at the Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

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.