Biosimilars and Biobetters

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

New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.

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.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

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

The American College of Rheumatology released a statement encouraging FDA to apply distinct names to biosimilars and maximize clarity in labels.

Inflectra is the second biosimilar to hit the market in the United States.

The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

A new study concluded although some mAb products have heterogeneous variants, these charge variants are associated with similar potency and pharmacodynamic profiles as originator molecules.

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

Sandoz reveals plans to complete a Phase III development program for Pfizer’s infliximab and file for registration in the EU.

On Feb. 9, 2016, an FDA Arthritis Advisory Committee will meet to discuss a biologics license application (BLA) for CT-P13 (Remsima), a proposed biosimilar to Janssen Biotech's Remicade (infliximab), by South Korea’s Celltrion in partnership with Pfizer. The BLA was submitted via the abbreviated 351(k) pathway and seeks to cover all of the eight indications that are approved for Remicade.

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

During a Q4 call with Merck, executives admitted the company's market share for Remicade (infliximab) has begun to dwindle. Remicade's share of the market decreased 5% (from 90% to 85%) from the third quarter to the fourth quarter. 

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

Amgen announces FDA will review the company’s BLA for ABP 501.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

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

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.