Regulatory

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.

Sandoz announced today that its biosimilar pegfilgrastim has been accepted for review by the European Medicines Agency (EMA).

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 23.

A new report by the RAND Corporation estimates the potential future cost savings gained from the use of biosimilars in the United States at $54 billion over 10 years, and examines future policy issues surrounding this important market.

The FDA has released a new set of educational materials concerning the nature and the prescribing of biosimilar therapies.

Drug prices in several disease areas outpace other healthcare expenditures and result in inadequate availability of essential medicines globally, according to a recently published review.

In addition to challenges related to reliable power, connectivity, transportation, and clean water, Puerto Rico