Regulatory

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.

The biologic has the potential to deliver effective treatment for adult patients with generalized myasthenia gravis, but it comes at a high cost.