Biosimilars

A proposed bill allowing biosimilar substitution in Georgia mirrors the state's generic drug substitution regulations.

A US House of Representatives vote to restore $85 million in sequestered funds to the FDA brings the hope of speeding up the approval process for brand name, generic, and biologic medications.

Payers will encourage the use of biosimilars where appropriate through the use of step edits, lower tiers, and novel strategies, said Steven Lucio, Senior Director, Clinical Solutions and Pharmacy Program Development at Novation.

Immunogenicity is an important consideration for all biologics, not just for biosimilars, noted Steven Lucio, Senior Director, Clinical Solutions and Pharmacy Program Development at Novation.

Interchangeability designations for biosimilars would make therapy substitutions easier for pharmacists, noted Steven Lucio of Novation, but the FDA has said they will not grant an interchangeability status to a biosimilar upon initial approval.

As attention on the management of biologic agents increases, payers anticipate the first biosimilar entrant into the US market.

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.