News

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 17, 2017.

An analysis of 53 switching studies reveals a variable level of good-quality evidence regarding switching from reference drugs to their biosimilars.

The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.

Last week’s Oncologic Drugs Advisory Committee recommendation that the FDA approve 2 biosimilar treatments brought Swiss drug maker Roche a step closer to inevitable competition from biosimilar treatments.

The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs such as nanomedicines, including drug-carrying liposomes—can be decreased, according to a new white paper.

The 2018 Medicare Physician Fee Schedule Proposed Rule, issued by CMS on July 13, considers changing a contentious billing code policy affecting biosimilar products.

Primary results from the ASSIST-FL Phase 3 clinical trial of GP2013, a proposed biosimilar of reference rituximab (Roche’s Rituxan, MabThera), showed that GP2013 is a viable rituximab biosimilar candidate for patients with previously untreated advanced follicular lymphoma.

On Tuesday, the FDA held a public meeting titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.”

On Monday night, Senators Mike Lee (R-Utah) and Jerry Moran (R-Kansas) announced their opposition to the Republican healthcare reform bill, the Better Care Reconciliation Act (BCRA).

A new report from GlobalData UK indicates that the market for HER2-positive breast cancer treatments could grow from $6.4 billion in 2015 to $9.89 billion in 2025, a compound annual growth rate (CAGR) of 4.4%.

A study published in the Journal of Clinical Pharmacy and Therapeutics found that SB5, a proposed biosimilar to AbbVie’s Humira, had pharmacokinetic (PK) equivalence to both European-sourced and US-sourced adalimumab.

A new report shows that most US-based health plans now cover at least 1 of the 2 FDA-approved biosimilars currently available in the marketplace.

Celltrion Healthcare, the marketing subsidiary of Celltrion Inc, has secured approximately $886.3 million—well over a previously projected $713 million—in its July initial public offering of 24.6 million primary shares.

Recent studies show that some patients who initiate treatment with biosimilar etanercept switch back to reference etanercept or other biologics. View the infographic or read more about the study here.

The Association of the British Pharmaceutical Industry (ABPI) announced his week that it has applied for judicial review of a new budget impact test implemented by the National Institute for Health and Care Excellence (NICE).

In its annual report, issued earlier this week, the Medicare program’s trustees said that Medicare will remain solvent until 2029, allowing the program to forestall triggering an Affordable Care Act provision to convene the Independent Payment Advisory Board.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of July 10, 2017.

Laboratorios Farmaceuticos ROVI (ROVI), a Spanish specialty healthcare company, reportedly expects to launch a biosimilar enoxaparin, a low-molecular-weight heparin (LMWH) product, in the European marketplace by the end of 2017. ROVI requested marketing authorization for its biosimilar product in Europe in 2014.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) convened today to consider Biologics License Applications (BLAs) for 2 biosimilar products: ABP 215, Amgen’s bevacizumab biosimilar candidate (referenced on Avastin), and MYL-1401O, Mylan and Biocon’s biosimilar trastuzumab candidate (referenced on Herceptin).

On Wednesday, the US House of Representatives passed the FDA Reauthorization Act of 2017 (FDARA), which, among other provisions, reauthorizes user fees for biosimilar product applications. The bill, sponsored by Representative Greg Walden (R-Oregon), was passed by a voice vote.

To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.

Biosimilar filgrastim is used to prevent chemotherapy-induced neutropenia and febrile neutropenia, but there exist only limited observational data concerning the use of granulocyte-colony stimulating factor treatments in patients who have non-Hodgkin’s lymphoma, including sub-types such as diffuse large B-cell lymphoma.

Last week, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled to invalidate AbbVie’s patent on a method of treating rheumatoid arthritis using adalimumab (Humira). The PTAB deemed the claims in question unpattentable because of their obviousness.

Treating patients with biosimilars of expensive biologic medications has the potential to reduce the costs of treatment for patients and payers, but the use of biosimilars has not translated into savings for most providers, which limits broader adoption of biosimilars, according to a recent analysis.

Spherix Global Insights’ recently released survey of 103 US gastroenterologists reveals that practitioners project significant growth in the use vedolizumab, golimumab, and Pfizer’s Inflectra, an infliximab biosimilar, for the treatment of ulcerative colitis over the next 6 months.

Biosimilar rituximab, marketed in Argentina as Novex, is subject to an active pharmacovigilance program that, according to Argentine law, must periodically report its status and results to regulatory authorities. In a recent study, researchers examined pharmacovigilance reports to compare the safety profile of biosimilar rituximab with that of its reference.

On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.

Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.