Kelly Davio

August 05, 2019

Biosimilar earnings were due in large part to the European launches of biosimilar trastuzumab (Kanjinti) and biosimilar adalimumab (Amgevita), which Amgen said are progressing in line with expectations and annualizing at more than $300 million.

August 05, 2019

According to Momenta, the decision is a result of “changes in the market opportunity associated with Humira patent litigation settlements.”

August 02, 2019

Data continue to accrue on the use of biosimilar infliximab, CT-P13 (Inflectra, Remsima), in a variety of disease states, and a recent study among patients with ankylosing spondylitis (AS) who were treated with the biosimilar demonstrated infrequent discontinuation of therapy.

August 01, 2019

A study published this week in PLoS Medicine suggests that brand-to-brand competition is not likely to reduce drugs’ list prices.

August 01, 2019

Celltrion announced that it has begun recruiting patients with inflammatory bowel disease in Ohio for a phase 3 clinical trial of its subcutaneous formulation of biosimilar infliximab, CT-P13 (Inflectra, Remsima). The study is intended to support an application for the formulation to the FDA.

July 31, 2019

July 2019 was a busy month for biosimilars on the regulatory front; not only did the FDA approve new products, but numerous policy proposals with a potential impact on biosimilar regulation were put forward by law makers.

July 31, 2019

The study sought to assess the efficacy, tolerability, and safety of CT-P13 versus its reference and versus adalimumab in patients with Crohn disease (CD).

July 30, 2019

In yesterday’s decision, the panel agreed with the district court that, during prosecution of the patent, Amgen “clearly and unmistakably surrendered salt combinations other than the particular combinations recited in the claims,” and that prosecution history estoppel bars Amgen from succeeding on its infringement claims under the doctrine of equivalents.

July 30, 2019

According to Mylan, the deal will allow the new company to “meaningfully expand the geographic reach” of its portfolio and its future products, including its complex generics and its biosimilars, into markets where Upjohn has existing infrastructure.

July 29, 2019

Senator Dick Durbin, D-Illinois, said that the “termination cliff” on the transition date creates a “perverse incentive that could delay approval” for biosimilar insulins, and said that the new legislation would create a faster approval path for lower-cost products.