Regulatory

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.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 14, 2017.

Yesterday, Biocon withdrew from the European Medicines Agency (EMA) its applications for the authorization of biosimilar trastuzumab and pegfilgrastim.

The European Medicines Agency announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s impending withdrawal from the European Union.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 7, 2017.

The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.

FDA Commissioner, Scott Gottlieb, MD, has created a new FDA working group of senior agency staff who will investigate ways to increase generic drug competition.

The US Supreme Court’s recent ruling in the case of Sandoz v Amgen led to industry speculation that biosimilar applicants could lack incentive to participate in the information exchange process with reference product sponsors, or the so-called “patent dance,” provided for under the Biologics Price Competition and Innovation Act (BPCIA).

The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. ​​The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.

The FDA’s biosimilar pathway has encouraged a robust product pipeline, but the fact that few biosimilar drugs have been approved by the agency thus far means that there is still some industry uncertainty on the FDA’s approach to this class of products.

The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.

The FDA’s Arthritis Advisory Committee (AAC) did not recommend the approval of Janssen Biotech’s sirukumab, a proposed monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis, over concerns about mortality.