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“You can’t have your cake—or in this case, your rebates—and a vibrant market for biosimilar competition too,” said FDA Commissioner Scott Gottlieb, MD.

Among commercial plans covering employees and their families, said Express Scripts, drug spending increased by just 1.5% per person, down from 3.8% in 2016. Calling this rate a “historic low,” Express Scripts said that this level of spending growth is the lowest that it has measured since 1993.

The trastuzumab biosimilar is priced 29.5% below the list price for the trastuzumab reference product, Herceptin.

On March 2, UK Prime Minister Theresa May delivered a speech on the future of the United Kingdom’s relationship with the European Union, calling for the United Kingdom to remain a member of the European Medicines Agency (EMA), and saying that the United Kingdom could commit to abiding by the rules of the EMA and “making an appropriate financial contribution” to the agency.

The proposed biosimilar references Genentech’s Pulmozyme, a biologic first approved in the early 1990s in both the European Union and the United States. Pulmozyme is used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis.

The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments, has announced that it has revised its approach to reviewing biosimilars.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 26, 2018.

The FDA and the European Medicines Agency announced today that the mutual recognition agreement on good manufacturing practice (GMP) inspections between the European Union and the United States now includes 4 additional EU member states.

India-based drug manufacturer Cadila Healthcare has announced that it is planning to file a Biologics License Application (BLA) for its biosimilar pegfilgrastim with the FDA by the end of 2019. To date, no developer has been successful in gaining regulatory approval in the United States or European Union for a biosimilar of the reference pegfilgrastim.

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.

Over the past 2 years, commercially insured patients enrolled in plans that had value-based contracts for certain high-cost drugs had lower copays for their medications than did patients enrolled in plans without such contracts. That finding comes from “Delivering Results for Patients: The Value of Value-Based Contracts,” a new report from the Pharmaceutical Research and Manufacturers of America (PhRMA).

The US Patent Trial and Appeal Board (PTAB) has decided that the Saint Regis Mohawk Tribe cannot claim sovereign immunity from inter partes review (IPR) of Allergan’s patents covering Restasis, and that the IPR proceedings on those patents can continue with Allergan as the patent owner.

Drug maker Biocon has received a Form 483 from the FDA after an inspection of its manufacturing facility in Malaysia.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 19, 2018.

The international initiative AllTrials has launched a new online tracking tool that publicly discloses which research entities have not reported data from clinical trials.

Pharmacy benefit manager Express Scripts and Walgreens Boots Alliance, Inc, have announced that they will expand their group purchasing efforts to include specialty drugs, including biologics and biosimilars.

Biocad, a Russia-based drug manufacturer, received approval for an infliximab biosimilar (referencing Remicade) from Russia’s Federal Drug Control Service last month. The company anticipates expanding to other markets as soon as later this year, or early 2019.

A white paper released this month by the Association for Accessible Medicines (AAM) says that brand-name drugs are behind high prescription drug costs, and that those costs aren’t only hurting patients’ financial wellbeing, but also endangering their health.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 12, 2018.

Ireland’s Minister for Health, Simon Harris, announced this week that Ireland is seeking to join Belgium, the Netherlands, Luxembourg, and Austria in their BeNeLuxA Initiative, a group that negotiates price deals on pharmaceuticals directly with manufacturers.

Yesterday, Eli Lilly announced that its anti–IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis.

Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.

Roche has released positive phase 2 data for its proposed novel anti–vascular endothelial growth factor and anti–angiopoietin-2 bispecific antibody, RG7716.

Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.

On Friday, the White House’s Council of Economic Advisors (CEA), an agency within the Executive Office of the President, released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad.”

“It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA,” Teva told investors.

Novartis announced on Thursday that the FDA has approved a label update for secukinumab (Cosentyx) to include moderate to severe scalp psoriasis, a particularly challenging form of psoriasis to treat, and a condition that affects approximately half of patients with psoriasis.

According to the recently released Personalized Medicines Coalition 2017 Progress report, the FDA approved a record number of 16 new personalized medicines in 2017.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 5, 2018.

The Federal Circuit on Monday affirmed a previous district court dismissal of drug maker AbbVie’s suit against MedImmune Limited over US Patent 6,248,516 (“the ’516 patent”).