News

A joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca has received a positive biosimilar opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Additional indications for Remsima SC, an infliximab biosimilar, are approved by the European Commission (EC).

Phase 3b trial results presented at American Academy of Dermatology Virtual Meeting Experience 2020 confirmed that Boehringer Ingelheim (BI)’s adalimumab biosimilar candidate is comparable to that of the reference product.

The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets.

President Trump signed 4 executive orders that would lower prices of prescriptions medications including insulin products and cancer medicines.

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.