Biosimilars

Two prominent trade organizations have taken opposing stances on the most recent issues within the biosimilars debate.

Spending on specialty medications is expected to increase 30% by 2017, a report from the IMS Institute for Healthcare Informatics predicts.

Steven Lucio of Novation discusses how Teva's Granix (tbo-filgrastim), which was filed through a 351(a) pathway, was approved for only 1 indication--and it was not the indication considered to be the "most definitive" for that particular product.

Manufacturing patents will play a larger role than molecule patents within the biologics development process, and these will also be a factor in terms of bringing complex products to market, argued Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.

The process of adding biosimilars to formularies will be much more rigorous than what the industry is accustomed to seeing in the generic molecule space, asserted Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.

Steven Lucio of Novation discusses why now is the time for pharmacists to educate themselves about biosimilars and the complexities surrounding biologic manufacturing.

Armada Health Care (Armada), the nation's largest specialty pharmacy group purchasing and channel management organization, is pleased to announce that it is supporting the Academy of Managed Care Pharmacy (AMCP) and its efforts on biosimilars within the specialty pharmacy channel.

Amid legislative shutdown, some drug review operations tied to residual user fees continue, but all nonemergency activities related to biosimilars have been suspended indefinitely.

The Generic Pharmaceutical Association petition recommends that the FDA use the active ingredient in a reference biologic when naming a biosimilar product.

Inflectra was approved for treatment of inflammatory conditions by the European Medicines Agency based on evidence that it was as effective, safe, and tolerable as its reference drug, Remicade.

The National Psoriasis Foundation Medical Board released a statement supporting the prohibition of biosimilar substitution pending the fulfillment of 7 key measures.

Another state sets up the pathway for biosimilar substitution; however, the proposed legislation comes with restrictions on that practice.

Experience with biologics and biosimilar products means a high level of trust from US payers, according to a report from BioTrends Research Group.

Debbie Stern of Rxperts highlights the various "unknowns" surrounding the potential cost savings of biosimilar products, such as interchangeability and the possible need for additional clinical trials.

The Biotechnology Industry Organization (BIO) and Oregon Bioscience Association (Oregon Bio) commend Oregon Governor John Kitzhaber for signing legislation designed to address the regulatory issues related to the interchangeability of biological medicines.

Illinois is now the 13th state to avoid enacting legislation that would slow patient access to biosimilars, which are new, affordable versions of costly brand biologic medicines that treat cancer, immune disorders and other complex diseases.

A bill passed by the Florida legislature would allow pharmacists to substitute biosimilars for brand-named biologics provided that a number of criteria are met.

A bill passed by the Florida legislature would allow pharmacists to substitute biosimilars for brand-name biologics provided that a number of criteria are met.

The Generic Pharmaceutical Association suggests that a eport on the global biosimilar market demonstrates the need for action to make biosimilar versions of biologic medicines available.

US manufacturers prepare for expanding biosimilar market opportunities as this exciting landscape takes shape. The production of biosimilars poses challenges as pharma looks to curb health care spending.

The industry is watching how biosimilars will affect the market and the challenges that lie ahead.