The Center for Biosimilars Staff

A new study comparing the clinical effectiveness of anti–tumor necrosis factor agents and the interleukin-6 inhibitor tocilizumab (Acterma) in patients with rheumatoid arthritis found that tocilizumab outperformed anti-TNFs in terms of effectiveness and drug survival.

Drug maker Shire has filed suit in a federal court in Newark, New Jersey, alleging that rival Allergan has violated antitrust laws in trying to preserve market share of its cyclosporine ophthalmic emulsion (Restasis) by blocking competition from Shire’s dry-eye drug, lifitegrast (Xiidra), on the Medicare Part D formulary.

If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.

Where does the market for infliximab stand in the United States? Our infographic provides a brief history of Remicade and its biosimilars.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 25, 2017.

The California legislature has passed SB 17, a major effort to ensure transparency in drug pricing.

The European Medicines Agency released results of an internal survey that asked staff to which proposed cities they would consider relocating. The lowest-ranking city was one to which only 6% of respondents were likely or very likely to relocate.

Republicans have cancelled plans to vote on the latest legislative effort to repeal and replace the Affordable Care Act after 3 members of the party announced that they would vote “no” on the Graham-Cassidy bill.

Biosimilar developer Hospira has been ordered to pay Amgen $70 million after a jury found that the drug maker infringed on Amgen’s US Patent Number 5,856,298 (the ‘298 patent), which covers erythropoietin.

Healthcare company Fresenius Kabi has initiated a $250 million expansion of its Illinois manufacturing location and acquired Merck KGaA's biosimilars business.

The FDA has approved, to date, 7 biosimilar treatments.

Judge James C. Mahan of the US District Court denied the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO)’s motion for a temporary restraining order that would force Nevada to “cease and desist all action implementing or enforcing” contested sections of Nevada’s Senate Bill 539.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 18, 2017.

The FDA has published its Biosimilar User Fee Act (BsUFA) rates for 2018. The Biosimilar User Fee Amendments of 2017 (BsUFA II) authorize the agency to assess and collect fees from applicants for biosimilar products from October 2017 to September 2022.

Samsung Bioepis has gained government clearance to begin a phase 3 clinical trial of its ranibizumab biosimilar in the Republic of Korea.

Last week, England’s National Health Service released a commissioning framework for biological medicines, including biosimilars.

This month, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), trade groups representing the biopharmaceutical and biotechnology industries, announced that they are challenging Nevada’s Senate Bill (SB) 539 in district court litigation.

At the AAM Biosimilar Council Conference 2017, Hillel Cohen, executive director of scientific affairs at Sandoz, disambiguated key terms in biosimilars.

Last week, Irish drug maker Allergan announced that it had transferred its patents for its cyclosporine ophthalmic emulsion, Restasis, to the Saint Regis Mohawk Tribe. Allergan said in a statement that the Tribe now owns all Orange Book-listed patents for the dry eye treatment, and that the Tribe is filing for a motion to dismiss an ongoing inter partes review on the basis of sovereign immunity.

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).

Adello Biologics, a New Jersey-based biosimilar developer previously named Therapeutic Proteins International, announced this week that its Biologics License Application (BLA) for a biosimilar filgrastim candidate has been accepted for review by the FDA.

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.

Sandoz announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed rituximab biosimilar. The drug is referenced on Rituxan, which is approved to treat blood cancers and immunological diseases.

Biosimilar developer Oncobiologics has announced a new strategic partnership with Singapore-based GMS Tenshi Holdings.

How much money can biosimilar filgrastim save, and how can health systems encourage uptake? This infographic outlines 7 key concepts.

Oncology trials often report on progression-free survival or overall survival, but the authors of an analysis presented during a poster session today at the European Society of Medical Oncology (ESMO) Congress argue that such endpoints are less sensitive then short-term overall response rate.

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

The US Senate’s Committee on Health, Education, Labor, and Pensions held the first 2 of its 4 full committee hearings on stabilizing the Affordable Care Act’s individual insurance market. Testifying on Wednesday and Thursday were state insurance commissioners and state governors, respectively. Across the 2 days of testimony, key themes emerged.