Business

FTC Seeking Information About J&J's Strategy for Brand-Name Infliximab, Remicade

July 30th 2019

By Allison Inserro

The Federal Trade Commission (FTC) issued civil subpoenas to Johnson & Johnson (J&J) in June as part of an antitrust investigation into the contracting practices for the autoimmune drug Remicade, the originator infliximab sold by its Janssen unit, the company said in a regulatory filing on Monday.

Federal Circuit Affirms Earlier Decision Dismissing Amgen's Suit Against Coherus

July 30th 2019

By Kelly Davio

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.

Mylan's Combination With Pfizer's Upjohn Unit Will Give Its Biosimilars Expanded Reach

July 30th 2019

By Kelly Davio

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.

Alvotech, Cipla Create Partnership to Sell Adalimumab Biosimilar

July 29th 2019

By The Center for Biosimilars Staff

Biopharmaceutical company Alvotech and Cipla Gulf entered into an exclusive partnership for the commercialization of AVT02, an adalimumab biosimilar, in certain emerging markets, the companies reported Monday. Alvotech's AVT02 is in phase 3 trials; the companies expect to file for approval with the European Medicines Agency and the FDA by early next year.

Facing No US Biosimilar Competitors, Humira Grows by $3.8 Billion

July 29th 2019

By The Center for Biosimilars Staff

In its second quarter earnings call, drug maker AbbVie revealed that, in the United States, Humira sales grew by $3.8 billion last quarter, up 7.7% from the prior year, with volume growth of approximately 7%.

Amendment to BPCIA Would Require FDA to Keep Reviewing Insulins Submitted Through NDAs

July 29th 2019

By Kelly Davio

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.

Developers Ask FDA for Clarity on Lingering Concerns in Biosimilar Guidance

July 26th 2019

By Kelly Davio

Fourteen parties have submitted comments on the guidance; in addition to other concerns with the document, including calls for clarification on the use of non-US comparator products and the potential for the waiver of bridging studies in the biosimilar development process, some drug makers called on the FDA to clarify issues associated with lot-to-lot variation and quality attributes.

The Top 5 Biosimilars Articles for the Week of July 22

July 26th 2019

The Center for Biosimilars® recaps the top stories for the week of July 22, 2019.

Court Calls Genentech's Actions In Trastuzumab Case "Contrary to the Spirit" of the BPCIA

July 24th 2019

By Kelly Davio

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

Biosimilar Provisions Feature Heavily in Senate Finance Bill

July 24th 2019

By Kelly Davio

The Senate Finance Committee has released its long-awaited chairman’s mark of the Prescription Drug Pricing Reduction Act of 2019. The bill, aimed at lowering the cost of drugs for American patients, contains a number of provisions that impact biosimilars.