Manufacturing, Biosimilars and Biobetters

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.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

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

A pilot project, beginning in 2017, will support the development of biosimilars.

Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

The biosimilar pathway permits licensure based on less than full clinical data.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

The company announced plans to begin shipping Inflectra to the US market in late November 2016.

The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.