News

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.

France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon has failed to comply with good manufacturing practice requirements for 3 of its biosimilar products manufactured at the company’s Bommasandra facility in Bangalore, India.

The 9 top-selling drugs of 2016 include numerous biologics. Learn what these drugs earned, and how biosimilars are impacting their global sales.

This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy.

The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.

Samsung Bioepis is reportedly undertaking shorter clinical trials in order to gain faster biosimilar approvals as the company seeks to compete with rival developers and to realize its first annual profits.

Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, with $228 billion in global sales in 2016. As many of these products face the loss of patent protection, biosimilar versions of these molecules may now enter the market, causing a shift in market share and driving changes in pharmaceutical companies’ strategies.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of July 3, 2017.

The expectation of achieving potentially significant health-system cost savings stemming from competition among an increasing number of available biosimilars has led to widespread interest in developing modeling techniques that can accurately estimate the economic impact of biosimilar adoption.

A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.

A recent study, published in Transfusion, analyzed 3 granulocyte-colony-stimulating factor treatments in an attempt to compare the mobilization efficiency of 2 innovator G-CSF treatments with that of 1 biosimilar treatment.

A survey and drug utilization analysis conducted among UK healthcare professionals found that 75% of respondents were aware that biosimilars were available on their local formularies, and 77% considered biosimilars to be either extremely or very important to save costs for the National Health Service.

To date, only limited data have been available concerning long-term clinical outcomes of switching patients with inflammatory bowel disease (IBD) from reference infliximab (Remicade) to a biosimilar treatment. A new study concludes that a switch to CT-P13 from reference infliximab was both safe and feasible.

In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.

An FDA official has said that the agency expects interchangeable biosimilars to come to market within 2 years and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.

Pegaspargase (marketed as Oncaspar), a biologic drug approved by the FDA in 2006 for acute lymphoblastic leukemia (ALL) as a component of multi-agent chemotherapy, has long gone unchallenged by biosimilar candidates. That could soon change, according to information recently reported by the Generics and Biosimilars Initiative (GaBI).

CT-P6, a proposed biosimilar of trastuzumab, showed equivalent efficacy to reference trastuzumab (Herceptin) as a neoadjuvant treatment in human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer, according to a recent phase 3 equivalence trial.

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.

As of July, 2017, 33 US states and Puetro Rico have enacted laws concerning biosimilar substitution.