Manufacturing, Biosimilars and Biobetters

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.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

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

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 directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

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.

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

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.

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

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Amgen announced the submission of a BLA with the FDA for ABP 501.

USP responds to FDA's draft guidance on the naming of biological products.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

Manufacturers challenge details in new policies designed to promote access to important therapies.