Biosimilars and Biobetters

R-Pharm Group, a private Russian pharmaceutical company, has opened a biopharmaceutical production plant in Yaroslavl, Russia, to produce biologics and biosimilars to treat autoimmune diseases and cancer. The facility, which has a line capacity is 2,000 L of cell culture per production cycle, is ready to be validated to US and Russia FDA and GMP requirements, the company reports.

CPhI outlines trends from the conference in Seoul.

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

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

Sandoz won FDA approval for its biosimilar version of Enbrel.

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

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.