Business

Amgen Claims Infringement of a Patent That Didn't Exist

May 1st 2020

By Tony Hagen

Trying to carve back its market share for Neupogen, its filgrastim originator product, Amgen is hoping product exclusivity can be backdated.

Pfizer Says Biosimilar Competition Cuts Both Ways

April 30th 2020

By Tony Hagen

Article

Pfizer is battling biosimilar competition as its brands lose exclusivity but it is fighting fire with fire, launching multiple biosimilars of its own. Biogen has extended its commercialization agreements for biosimilars and said its earnings picture improved in the first quarter of 2020.

In Europe, Secondary Patents Can't Stop Biosimilars, Study Says

April 29th 2020

By Deana Ferreri, PhD

Article

European investigators say their analysis of court cases involving innovator monoclonal antibodies suggests secondary patents have generally failed to stop biosimilar competition.

Novartis Reports 31% Growth in Biosimilar Division

April 28th 2020

By The Center for Biosimilars

Article

With a growing portfolio of biosimilars, Novartis saw a 31% increase in biopharmaceutical sales for the first quarter of 2020, despite the pandemic.

Genentech's Misfire on Kanjinti Creates Opening

April 28th 2020

By Tony Hagen

Article

Taking an abundance of time to file a motion to block Kanjinti from coming to market, Genentech unwittingly may have tipped the scales in favor of biosimilar applicants.

Henlius Manufacturing Plant Gains European Stamp of Approval

April 27th 2020

By Tony Hagen

Article

Henlius Biotech said its manufacturing facility has met European standards for production of its trastuzumab biosimilar candidate, which the company said is "a passport" for potential commericialization across the globe.

Cheryl Larson Discusses Employer Initiatives to Battle Costs of Care

April 25th 2020

By The Center for Biosimilars

Article

Cheryl Larson, president and chief executive officer of the Midwest Business Group on Health, discusses the sticker shock of rising specialty drug costs and how biosimilars are going to be incorporated into efforts to push back against this medical inflation.

Samsung Bioepis Sees Wide Open Market for Its Trastuzumab

April 24th 2020

By Tony Hagen

Article

Samsung Bioepis isn't flinching on its trastuzumab biosimilar launch schedule, COVID-19 and 4 other biosimilar competitors notwithstanding, said Sang-Jin Pak, MD, executive vice president of the company's Commercial Division.

Wong Discusses Strength of Regulatory Actions

April 23rd 2020

By The Center for Biosimilars

Article

Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.

Lannett Will Discuss Insulin Glargine Application With FDA

April 8th 2020

By Tony Hagen

Article

Longtime generics manufacturer Lannett is moving an insulin glargine biosimilar development plan forward and announced an upcoming meeting with the FDA. The agent would compete with the reference product Lantus.