Regulatory

Three European nations are amending their policies in order to create better conditions for biosimilar uptake and the cost savings that biosimilars provide to health systems.

Sandoz, a division of Novartis, announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed adalimumab biosimilar (referencing AbbVie’s Humira).

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, describes how the FDA has changed under its current leadership.

On Thursday, the FDA announced that it is taking new steps in 2018 to make the development and approval of biosimilars more efficient.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 8, 2018.

FDA Commissioner Scott Gottlieb, MD, has said that he is open to rethinking the aspects of a 35-year-old law that create incentives for drug companies to develop orphan drugs for rare diseases affecting fewer than 200,000 people, because the market has changed since the law was passed.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, responds to Allergan's recent transfer of patents to a soverign entity, and gives 2 takeaways for industry.

During the second day of the 36th Annual J.P. Morgan Healthcare Conference, Amgen and Mylan highlighted their progress with biosimilar therapies, while Roche and Sanofi focused on progress with innovator products and combinations that may help insulate them from biosimilar and follow-on competition.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains how the upcoming transition of follow-on biologics to regulation as biosimilars could create a "regulatory dead zone."

In August 2017, Sandoz, a Novartis company, announced the launch of its etanercept biosimilar (Erelzi) in Canada. In December 2017, Ontario became the most recent Canadian province to add the biosimilar etanercept to its public drug plan for the treatment of multiple inflammatory diseases.

In November 2017, the Federal Trade Commission (FTC) held a meeting, comprising industry groups representing generic and brand-name drugs, pharmacies, and pharmacy benefit managers, to discuss possible solutions to increase competition and lower the cost of drugs in the United States. Afterward, numerous stakeholders submitted comment letters to the FTC addressing competition issues.

Writing in a Perspectives article, Michele K. Dougherty, PhD, and colleagues at the FDA predict the success of the agency’s biosimilars program and anticipate that as biosimilar development programs continue to mature, there will be an influx of biosimilar approval applications filed at the agency, and that the FDA and the biopharmaceutical industry will continue to build on the lessons learned from early biosimilar development programs.

The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.

Mumbai-based Glenmark Pharmaceuticals launched a biosimilar adalimumb, Adaly, in the Indian marketplace this week, following Hetero's launch of Mabura.

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

The FDA has released new draft guidance aimed at encouraging generic drug competition as part of its continued implementation of the Drug Competition Action Plan.

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

In 2017, the FDA more than doubled the number of drugs it approved compared with the previous year, with 46 novel medicines receiving the FDA’s endorsement in 2017.

Mylan and Biocon ended 2017 with more positive news for their biosimilar program; on December 29, 2017, the partnership announced that Brazil’s National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar.

A new paper argues that the addition of a single data element—namely, a batch or lot number—would enhance the value of pharmacovigilance systems for biosimilars.

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

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

In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.

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

The United States now has 9 FDA-approved biosimilars. Our latest infographic breaks down what you need to know about these products.

The European risk management plan (RMP) contains relevant safety information for specific products, with characterizations of both potential and identified risks, including real-world data. Because the RMP is systematically updated, the RMP can provide early indications of differences in product safety between originator and biosimilar therapies.

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.

Biologic drugs play a key role in the US healthcare market, as they are often the standard of care for treating complex diseases, many of which require long-term treatment. With the FDA’s approval of biosimilars of several important biologic treatments, and with a significant pipeline of biosimilars still in development, it is expected that many biosimilars will be introduced to the US market in the next several years.

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