Kelly Davio

July 24, 2017

Pfizer has announced positive top-line results from a comparative, confirmatory safety and efficacy study of an investigational bevacizumab biosimilar referenced on Avastin.

July 22, 2017

The American Society of Clinical Oncology (ASCO) has issued an official position statement addressing the affordability of cancer drugs. The position was guided, the organization says, by several key principles.

July 21, 2017

The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.

July 19, 2017

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

July 17, 2017

A new report shows that most US-based health plans now cover at least 1 of the 2 FDA-approved biosimilars currently available in the marketplace.

July 15, 2017

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).

July 14, 2017

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.

July 14, 2017

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).

July 13, 2017

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.

July 12, 2017

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.