Biosimilars and Biobetters

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

Alvotech and Advanz Pharma have signed a strategic partnership agreement for the supply and commercialization of five biosimilar candidates in Europe.

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

Biosimilar data analysis must demonstrate a correlation between structure and function.

Biocon Biologics will acquire Viatris’ global biosimilars business, including the company’s portfolio of in-licensed biosimilar assets, in a transaction valued at over $3.3 billion.

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.

The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.