Biosimilars and Biobetters

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

Thirty percent of current Remicade patients could be eligible for a switch to competitors such as Inflectra, according to estimates, although J&J doubts this will occur in the United States in 2016.

FDA said in briefing documents ahead of a July 13, 2016 meeting that Sandoz’s biosimilar GP2015 has “no clinically meaningful differences” with the US-licensed and EU-licensed versions of Enbrel (etanercept) in terms of safety, purity, and potency.

The assay will provide information on biosimilar comparability.

Capacity for complex therapeutics is become increasingly difficult to predict.

Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.

Technology advances enable contract service providers to keep pace with the demands of existing and emerging biologic-based therapies.

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

An article in Nature Reviews Drug Delivery reports the clinical success rates of biologics, and these numbers differ from those recently highlighted in a similar BIO study.

Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.

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.