Biosimilars

The first biosimilar product in the United States has been approved, and the time is now for specialty pharmacists to become familiar with the use and regulation of these drugs.

Biosimilars are finally a reality in the US drug market, but a report warns regulatory decisions may limit future savings from the drugs.

FDA approves Zarxio for the same indications as Neupogen.

New recommendations involve drugs containing several adapalene formulations.

Raulo Frear, PharmD, general manager of OmedaRx, discusses the ramifications of biosimilars hitting the US market.

Filgrastim is indicated to decrease the incidence of infection in patients with non-myeloid malignancies who also are receiving myelosuppressive anti-cancer drugs.

The Academy of Managed Care Pharmacy today supported the U.S. Food and Drug Administration's use of "an expedited approval process" for biosimilars to encourage the development of both new and more affordable treatments for such serious conditions as cancer, multiple sclerosis and rheumatoid arthritis.

Landmark generic labeling rulings may foreshadow the issues that lie ahead when biosimilars enter the US market.

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.