News

Cadila Pharmaceuticals has launched a bevacizumab biosimilar referencing Avastin in India. Bevacizumab is used for the treatment of colorectal, breast, and lung cancers, among others.

For Biocon, overall revenues were up during the fiscal quarter that just ended, driven by strong revenues in its biosimilars and generics operations.

Here are the top 5 biosimilars articles for the week of July 20, 2020.

As capacity at its 3 existing plants begins to run out, Samsung Biologics will add a fourth plant to its Incheon, Republic of Korea, site.

The company saw a 7% decline in biosimilar revenues in the second quarter of 2020 compared with the same quarter in 2019.

China-based Bio-Thera Solutions is breaking into the growing Russian biosimilar market by licensing the marketing rights for its unapproved golimumab biosimilar to Russian biopharmaceutical company Pharmapark.

Biosimilar misinformation takes many forms, some of it institutionalized in the form of word usage and some of it deliberately disparaging, 2 executives of Sandoz and Boehringer Ingelheim contend.

In a deal with Voluntis, Biocon Biologics aims to extend the appeal of its insulin products by offering a digital titration device for self-management of insulin dosage.

In a webinar this week, experts discussed the business dynamics that prevent providers from being able to choose the lowest-cost biosimilars.

A recent article lays out some of the hurdles the biosimilars industry faces, from the perspectives of oncology providers.

With insulin originator product patents expiring, drug companies are seeking to extend exclusivities via patents on injectors and other delivery products.

As part of a project to build the first biosimilar factory in Malaysia, one of the initial products would be halal certified.

Although devastating in its toll on human life, the coronavirus disease 2019 will likely bring new understanding and technology and leave us better prepared to manage the next health threat of this scope.

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.