Regulatory

On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use issued positive opinions on 2 biosimilar candidates.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 11.

The FDA has approved Mvasi, the first biosimilar bevacizumab (Avastin).

During a panel on the second day of the 2017 AAM Biosimilars Council Conference, held in Washington DC, regulatory leaders from Pfizer and Sandoz shared their experiences with the development of their biosimilar products: epoetin alfa (Epogen) and etanercept (Erelzi), respectively.

At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”

At the 2017 AAM Biosimilars Council Conference, policy experts addressed the question of how biosimilar developers can navigate the complex and challenging biologics marketplace in the United States.

Christine Simmon, senior vice president of policy and strategic alliances for the Association for Accessible Medicines (AAM) and executive director of The Biosimilars Council, told The Center for Biosimilars® at the 2017 AAM Biosimilars Council Conference that upcoming product approvals in the biosimilar space are exciting prospects not only for the industry, but, most importantly, for patients.

How can the US healthcare system learn from the European Union on market penetration for biosimilar products?

The FDA has issued new draft guidance on how biologic product sponsors should address postapproval changes in chemistry, manufacturing, and controls.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 4, 2017.

This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017. The heavily redacted form notes 12 observations.

The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

Competition for the $16 billion market for Humira is heating up with new approvals for adalimumab biosimilars in the United States and European Union.

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

The FDA has granted tentative approval of Sanofi’s follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofi’s insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes.

This week, FDA commissioner Scott Gottlieb, MD, announced that the agency’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new agreement to integrate drug review programs with facility evaluations and inspections.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 28, 2017.

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.

Genentech, a member of the Roche Group, announced on Sunday that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted a priority review for the company’s obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for patients who have previously untreated follicular lymphoma.

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

Coherus BioSciences today announced positive topline results for the first of 3 pharmacokinetic bioequivalence studies comparing CHS-1420, an adalimumab biosimilar candidate, and European-sourced reference Humira.

The approval for adalimumab-adbm comes a year after the first adalimumab biosimilar, by Amgen, was approved in September of 2016.

Roche’s sales of ranibizumab (Lucentis), already depleted by competition from such products as afilbercept (Eylea), face upcoming erosion from biosimilar competition.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.

Genentech, a member of Roche Group, has announced that the FDA has accepted its Biologics License Application and granted priority review for emicizumab, a once-weekly subcutaneous prophylaxis for adults, adolescents, and children with hemophilia A who have factor VIII inhibitors.

The FDA has signed a new confidentiality agreement with the European Commission (EC) and the European Medicines Agency (EMA). The agreement will allow the FDA to share with the EC and EMA nonpublic, commercially confidential information (including trade secrets) related to inspections.

The United Kingdom (UK) has issued a position paper on ensuring a smooth economic transition from the European Union (EU) in relationship to the availability of goods, including pharmaceuticals.

A recent paper, published in BioDrugs, argues that, in biosimilar development, bridging studies between locally licensed and internationally licensed reference biologics may be unnecessary.