News

Samsung Bioepis’ etanercept biosimilar, SB4, has been available in multiple markets since it was authorized by the European Commission in 2016, and this week, a new systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases.

The fact sheet is being released as Canada awaits the launch of additional anticancer biosimilars.

Since Democrats control the House, Speaker Nancy Pelosi, D-California, is a major factor in determining how fast this agreement moves through Congress. One of the major Democratic points of concern is how prescription drugs, namely biologics, are handled in the USMCA.

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.

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

Mylan and Biocon announced this week that they have launched their biosimilar trastuzumab, Ogivri, in Australia. Ogivri, referencing Herceptin, is the first trastuzumab biosimilar to launch in the Australian marketplace and is listed on the nation’s Pharmaceutical Benefit Scheme.

Will biosimilars improve public health? Policy makers should look to that question as they sort through possible solutions, the authors say.

The Center for Biosimilars® recaps the top stories for the week of July 29, 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.

“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.