Biosimilars

Significant challenges remain due to lack of FDA action on existing biosimilar approval guidelines.

Pharmacists will play key role in bringing biosimilar medications to US markets, both before the therapies receive FDA approval and after they become available.

GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.

RAND Corporation projects biosimilars to cause an approximately 4% reduction in total US biologic spending from 2014 to 2024.

Biosimilars are an estimated 30% cheaper than branded biologics

Biologics License Application filed for filgrastim by Sandoz.

Survey finds an overwhelming number of seniors are unaware of what biosimilars are.

Executive at Pfizer discusses the various regulatory roadblocks and market challenges for biosimilars in a Q&A with Specialty Pharmacy Times.

CVS Caremark specialty pharmacy executive discusses the evolution of a patient-centered health care ecosystem.

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.