Business

Drug maker Amgen has announced a deal to partner with Simcere Pharmaceutical Group to co-develop and commercialize 4 biosimilar treatments in China.

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.

Drug maker Amgen announced today that it has reached a global settlement with AbbVie, developer of reference adalimumab (Humira), over Amgen’s biosimilar adalimumab, Amgevita.

Amgen has filed a news Biologics Price Competition and Innovation Act (BPCIA) suit against rival drug maker Mylan.

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 issued a complete response letter (CRL) for Johnson and Johnson’s proposed rheumatoid arthritis (RA) drug, sirukumab. Janssen Biotech, a division of Johnson and Johnson, had filed a Biologics License Application (BLA) for the interleukin-6 (IL-6) inhibitor, including data from a global phase 3 clinical development program, in September 2016.

At the 26th Congress of the European Academy of Dermatology and Venereology in Geneva, Switzerland, Sandoz announced positive data from a phase 3 confirmatory study to compare the efficacy and safety of Sandoz’s proposed biosimilar adalimumab, GP2017, with its reference.

Scott Gottlieb, MD, Commissioner of the FDA, has signaled that while biosimilars are on the rise, they need a boost from stakeholders if development of these therapies will continue to grow.

Drug maker Pfizer announced today that it has filed a district court lawsuit in the Eastern District of Pennsylvania against Johnson and Johnson.

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

In recent years, a wrench has been thrown into the patient care equation.

This Rheumatic Disease Awareness Month, Stanley Cohen, MD, medical director of the Metroplex Clinical Research Center and clinical professor of internal medicine at the University of Texas Southwestern Medical School, has a message for patients: biosimilar treatments are just as safe and effective as originator biologics in treating rheumatic diseases.

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.

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.

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).

Providing an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.

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?

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

Coherus BioSciences has announced that its petition for inter partes review of AbbVie’s US Patent 9,085,619, covering the formulation of adalimumab (Humira), was not instituted by the Patent Trial and Appeal Board.

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.

Seth D. Ginsberg, co-founder of Global Healthy Living Foundation, told The Center for Biosimilars®, “Currently the benefit of rebating and pricing of all infused drugs goes to the payers, health systems, hospitals and physicians, not the patients. Until patients participate in such savings, infused drug pricing has nothing to do with them.”

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

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

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

A retrospective study using a large US claims database of patients with moderate to severe psoriasis suggests that extensive above-label use of etanercept, adalimumab, and ustekinumab occurs in many patients who take these biologics, and leads to higher costs.