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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.

“We wish biosimilar competition would efficiently lower biologics prices to the socially optimal level of marginal economic cost,” wrote Bach and coauthors. “But, in this case, the ideological preference for competition needs to be put aside for a more effective, efficient, and economically justified approach of regulating biologics as natural monopolies.”

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

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.

The chairman and the ranking member of the Judiciary Subcommittee on Courts, Intellectual Property and the Internet in the House of Representatives, proposed a bipartisan bill to amend the patent dance in the Biologics Price Competition and Innovation Act (BPCIA) by capping the number of some types of patents that may be claimed by the maker of the reference product.

The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking to authorize importation of drugs from Canada. The second pathway would allow manufacturers to import versions of FDA-approved drugs that are sold in other countries.

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.

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).

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.

At Coherus, we've made our decision. We have only sought parity insurance coverage with originator biologics, giving doctors and patients the freedom to make the right decision for them, and that's a policy we'll continue.

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.

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.

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.

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%.

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.

Novartis, developer of the brand-name Lucentis, announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted the drug a positive opinion for the treatment of retinopathy of prematurity in infants.

Mixed cryoglobulinemic vasculitis—a rare disorder that is characterized by the presence of abnormal proteins in the blood that become insoluble at low temperatures and restrict blood flow—may be successfully managed with the use of rituximab as a generally well tolerated, glucocorticoid-sparing therapy.

The FDA Friday issued a black box warning for the 10-mg, twice-daily dose of tofacitinib, sold under the names Xeljanz or Xeljanz XR; the drug is an oral, small-molecule Janus kinase (JAK) inhibitor. In addition, this week researchers released phase 3 study results of an investigational JAK inhibitor, filgotinib; the drug showed a clinical response, but the researchers said additional work is needed to assess long-term efficacy and safety.

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

A patient-level simulation model using real-world data from Finland evaluated the cost-effectiveness of abatacept, tocilizumab, and anti–tumor necrosis factor (anti-TNF) therapies as compared with rituximab in patients with rheumatoid arthritis (RA) who received previous treatment with an anti-TNF agent.

JCR Pharmaceuticals, together with partner Kissei Pharmaceutical, is currently developing a darbepoetin alfa biosimilar, JR-131, referencing Aranesp. Darbepoetin alfa is used to treat anemia caused by chronic kidney disease or by chemotherapy.

Among the data that supported the biosimilar’s approval was a phase 3 study in patients with advanced nonsquamous non–small cell lung cancer. This week, researchers published detailed findings from that study.

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

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.

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.

The FDA Tuesday approved Samsung Bioepis’ Hadlima (adalimumab-bwwd), referencing Humira.

A bipartisan bill introduced in the Senate Monday calls for cutting insulin prices up to 75% via a measure aimed at insurers and pharmacy benefit managers (PBMs). The bill, introduced by Senator Jeanne Shaheen, D-New Hampshire, would prohibit PBMs and insurers from receiving rebates for insulin if the drug maker has lowered its 2020 list prices to 2006 levels.

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

This month, the president and chief executive officer of Green Shield Canada, the fourth-largest private payer in Canada, hailed British Columbia’s strategy as “forward-thinking” and “essential to maximizing opportunities in healthcare.”