Biosimilars and Biobetters

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

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.

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.

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

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.

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

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 approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

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

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

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 GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

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.

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.

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.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.