Manufacturing, Biosimilars and Biobetters

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

Early adopters are benefiting from lower costs and increased productivity.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

Reliable, high-quality products require innovative analytics and production.

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.

Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

A controversial naming convention attempts to explain important distinctions between biologic drugs and their biosimilar counterparts.

Aurobindo has added four cell-culture derived biosimilars to its product line.

Despite the threat of competition, both from biosimilars to Humira and new therapies that work through other mechanisms of action, AbbVie says Humira is still number one.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.