Regulatory

On Tuesday, the FDA held a public meeting titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.”

The Association of the British Pharmaceutical Industry (ABPI) announced his week that it has applied for judicial review of a new budget impact test implemented by the National Institute for Health and Care Excellence (NICE).

Laboratorios Farmaceuticos ROVI (ROVI), a Spanish specialty healthcare company, reportedly expects to launch a biosimilar enoxaparin, a low-molecular-weight heparin (LMWH) product, in the European marketplace by the end of 2017. ROVI requested marketing authorization for its biosimilar product in Europe in 2014.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) convened today to consider Biologics License Applications (BLAs) for 2 biosimilar products: ABP 215, Amgen’s bevacizumab biosimilar candidate (referenced on Avastin), and MYL-1401O, Mylan and Biocon’s biosimilar trastuzumab candidate (referenced on Herceptin).

On Wednesday, the US House of Representatives passed the FDA Reauthorization Act of 2017 (FDARA), which, among other provisions, reauthorizes user fees for biosimilar product applications. The bill, sponsored by Representative Greg Walden (R-Oregon), was passed by a voice vote.

To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.

Last week, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled to invalidate AbbVie’s patent on a method of treating rheumatoid arthritis using adalimumab (Humira). The PTAB deemed the claims in question unpattentable because of their obviousness.

On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.

Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.

France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon has failed to comply with good manufacturing practice requirements for 3 of its biosimilar products manufactured at the company’s Bommasandra facility in Bangalore, India.

This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy.

The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.

A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.

An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.

The Biosimilar User Fee Act of 2012, which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September.

The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.

Celltrion and Teva announced today that the FDA has accepted the companies’ Biologics License Application (BLA) for CT-P10, a proposed rituximab biosimilar. FDA regulatory action is expected in early 2018.

On June 28, Elaine Blais and Willy Jay, partners at Goodwin Proctor LLP, held a webinar discussing the Supreme Court’s Decision in the case of Sandoz v Amgen. While the court provided some much-needed clarity surrounding requirements of the Biologics Price Competition and Innovation Act “patent dance,” as Blais and Jay pointed out, the court’s ruling left a number of important questions unresolved.

The FDA rejected, for a second time, Pfizer’s application for approval of its biosimilar epoetin alfa (Epoetin Hospira), a colony-stimulating factor indicated for anemia, biosimilar to Epogen and Procrit.

FDA Commissioner Scott Gottlieb, MD, has unveiled a new plan to facilitate increased competition in the prescription drug market through approval of more lower-cost, generic medications.

At the 8th Annual Summit on Biosimilars, a panel of legal experts reviewed lessons learned from the first 18 months of biosimilars in the United States, and looked ahead to the question of how these drugs will gain acceptance and market uptake.

Amgen announced Monday that the FDA has accepted its supplemental Biologics License Application for denosumab.

Pharmaceutical manufacturers, pharmacy benefit managers, and various trade groups respond to the recent Supreme Court decision on the 6-month marketing rule post FDA approval for biosimilars.

Republican Nevada Governor Brian Sandoval yesterday signed into law the country’s strictest requirements for drug companies to show how they set prices for certain prescription drugs, with a specific focus on insulin.

News of the landmark Supreme Court ruling in the case of Sandoz v Amgen broke during the Monday session of the 8th Annual Summit on Biosimilars, a meeting of legal and pharmaceutical industry professionals convened in New York City. In a previously scheduled—and swiftly updated—discussion of the case, a panel of attorneys grappled with the ruling and its implications for the industry.

Last week, Amgen and Allergan announced that the FDA will review data supporting the firms' Biologics License Application for ABP 215, a bevacizumab (Avastin) biosimilar candidate.

Coherus BioSciences announced that it has been issued a complete response letter by the FDA in response to its biologics license application for CHS-1701, a pegfilgrastim biosimilar candidate.