News

Celltrion Healthcare said an antiviral drug candidate is moving along in trials as a potential treatment for coronavirus 2019 (COVID-19).

Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but they anticipate that the success rate will improve with experience and improved guidance.

Here are the top 5 biosimilars articles for the week of July 13, 2020.

An upcoming webinar from MJH Life Sciences™ will address the payer rebate deals that limit provider choice of biosimilars and complicate clinical pharmacy operations.

Wide variation in treatment patterns for Crohn disease is attributable to failures to translate evidence uniformly and cost barriers. Authors of a new report have formulated algorithms to help reduce heterogeneity in treatment of patients.

Polpharma Biologics said it is close to finishing its integration of Bioceros, a company it acquired 4 years ago. The acquisition gave Polpharma an advanced cell line development platform, and with a bioreactor facility nearing completion, the company said it is poised for growth.

Here is a collection of some of our most recent clinical trial news articles.

The transition from reference to biosimilar etanercept was safe and effective in patients with stable rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA), according to updated findings from the BENEFIT study.

The House Appropriations Committee has called upon CMS to increase access to biosimilars.

The rise of biologics as a class of prescription spending is fueling a trend toward longer exclusivity periods, which ultimately makes access more remote, authors of a new study said.

The Generic and Biosimilar Medicines Association in Australia reported its 2020 Biosimilar Awareness Week was successful, with educational messages from the event reaching over 540,000 Australians via social media.

A victory for Amgen and a defeat for Sandoz pushes biosimilar competition in the etanercept market out to 2029 unless Sandoz or Samsung Bioepis can eke out headway against Enbrel's patent wall.

India's medical authorities approve Biocon Biologics' itolizumab, an anti-CD6 IgG1 monoclonal antibody, for emergency treatment of cytokine release syndrome in patients with coronavirus disease 2019 (COVID-19).

Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.

Wui-Jin Koh, senior vice president and chief medical officer of the National Comprehensive Cancer Network (NCCN) laid out the current initiatives that organization has taken to promote the use of biosimilars in oncology settings.

Here are the top 5 biosimilars articles for the week of July 6, 2020.

With a couple of recent biosimilar approvals, the FDA has vastly improved on the pace from the first 5 months of this year, during which no biosimilars were approved.

In court filings this week, Genentech and Amgen laid to rest their long-running dispute over the marketing of bevacizumab and trastuzumab biosimilars that challenged Genentech's dominance of the market for those products.

The European Commission has granted market authorization to Sanofi for its insulin aspart biosimilar, making it the first approved biosimilar to NovoRapid for the region.

The FDA has approved Fujifilm Kyowa Kirin Biologics's Hulio adalimumab biosimilar, making it the sixth adalimumab biosimilar approved in the United States. However, none will be launched before 2023 because of the strength of AbbVie's exclusivity rights for Humira, the reference product. Hulio launched in Europe in 2018.

Biocon is planning to list its biosimilar entity, Biocon Biologics, on the capital markets in the next few years. Although this move will allow the entity to expand on current projects, it also raises questions about whether it will be successful.

Genentech seeks to block the marketing of Samsung Bioepis’ proposed bevacizumab biosimilar, saying the company infringed multiple patents when submitting an FDA approval application.

Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the part of gastroenterologists and patients, particularly when it comes to extrapolation to off-label uses, according to a new study.

A review laid out ways for nurses to address patients’ questions on biosimilars in order to help them take on the role of improving utilization rates in cancer treatment.

Wayne Winegarden, PhD, director of the Center for Medical Economics and Innovation, explains that misaligned incentives are preventing the United States from realizing full benefit from biosimilars.

In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.

After a study from India suggested a higher incidence of adverse reactions in patients using biosimilar filgrastims, 2 European biosimilar consultants and oncologists raised objections to the study’s methodology.

Sandoz Canada launched a digital campaign to provide fact-based materials on biosimilars in hopes of spreading awareness on the benefits of biosimilars for physicians and patients.

A Senate bill that seeks to establish a shared savings model to help increase access and encourage physician use of biosimilars was introduced.

Cardinal Health Specialty Solutions has produced a Rheumatology Insights report that includes results from a survey of over 100 US-based rheumatologists on their perceptions and experiences with biosimilars in rheumatology thus far.