Regulatory

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.

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

This week, Leah Christl, PhD, associate director for therapeutic biologics, Center for Drug Evaluation and Research (CDER), FDA, and Sue Lim, MD, medical officer at the FDA’s Office of New Drugs, held a webinar to discuss the regulatory framework for biosimilars as well as the development and approval process for these drugs.

The Center for Biosimilars recaps the top 5 articles for the week of December 4.

USV has announced that the European Medicines Agency (EMA) has accepted for review its application for a proposed pegfilgrastim biosimilar.

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.

Robert Cerwinski, JD, partner at Goodwin, explains the differences between European and US patent challenges for biologics.

The Center for Biosimilars recaps the top 5 articles for the week of November 27.

November saw a number of developments related to biosimilar therapies for rheumatologic indications, with new data published, policies adapted, and devices launched.

A recent report by the World Health Organization (WHO) showed that nearly 1 in every 10 drugs is falsified or substandard, and estimates the net worth of the industry for such drugs at nearly $30 billion.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of November 20.

The United Kingdom's National Institute for Health Research (NIHR), part of the National Health Service (NHS), has created a website to educate the public about biosimilar drugs.

This past week, the FDA began the long-awaited process of adding a 4-letter suffix devoid of meaning, to the end of newly approved biologics’ nonproprietary names.

Results of a new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) shows that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars,

Low levels of competition among drug makers can lead to product shortages and increased generic drug prices, and a recently published study in Global Health suggests that mergers and acquisitions, which reduce the number of players in the pharmaceutical field, should be closely monitored by regulatory authorities.

Amsterdam, Netherlands, has won its bid to become the new home of the European Medicines Agency.

Samsung Bioepis announced today that it has received the European Commission's (EC) marketing authorization for its biosimilar trastuzumab, SB3, for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. SB3 is the first biosimilar trastuzumab, referenced on Roche’s blockbuster Herceptin, to receive European regulatory approval.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of November 13.

Steinar Madsen, MD, medical director of the Norwegian Medicines Agency, shared lessons learned from the Norwegian experience with biosimilars in a Wednesday talk at the SMi Biosimilars North America conference.

At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.

Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses current FDA guidance on the naming and labeling of biosimilar treatments.

The South Centre, an intragovernmental organization of developing nations headquartered in Geneva, Switzerland, has issued a new report on biosimilars that calls on regulatory bodies to institute an approval pathway for “biological generics” in favor of biosimilars.

Boehringer Ingelheim (BI) announced today that its adalimumab biosimilar, Cyltezo, has been granted marketing authorization by the European Commission to treat multiple rheumatic diseases after having received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2017.

Samsung Bioepis announced this week that it has gained regulatory approval in the Republic of Korea for its trastuzumab biosimilar, SB3.

Drug makers Amgen and Allergan announced on Friday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ABP 215, the companies’ bevacizumab biosimilar. CHMP recommended the biosimilar for approval for the treatment of multiple cancer indications.

During yesterday’s Federal Trade Commission public workshop on drug pricing competition, Scott Gottlieb, MD, Commissioner of the FDA, called on drug makers to “end the shenanigans” that delay drug competition in the US marketplace.

In the evolving world of biologic therapies, a class of follow-on biologics—so-called "biobetters"—is emerging as a new category of products.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 30.

The FDA has announced that the agency will recognize 8 European regulatory agencies as capable of conducing manufacturing facilities inspections that will meet FDA requirements. The agencies named are those of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom.

The high cost of prescription drugs, the need for more competition in the marketplace, and the potential for biosimilars to provide substantial savings were key topics among biosimilars stakeholders in the month of October.