Biosimilars

Legal challenges, drug shortages, and regulatory issues create hurdles for biosimilars in the US market.

More biosimilar approvals may lead to lower costs.

Douglas Samojedny, RPh, director of Pharmacy Operations at Pharmacy Advantage, discusses how biosimilars could impact specialty pharmacy into the immediate future.

Mylan gains global licenses for its biosimilar to trastuzumab (Herceptin).

While biosimilars have the potential to slow the dramatic rise in the overall drug spend, many questions need to be answered.

GP2017 observed to reduce symptoms among patients with moderate-to-severe chronic plaque psoriasis.

Over the last few months, new developments have taken place within the biosimilar market including new drug approvals and guidance documents released by the FDA.

The interchangeability designation demonstrates that the efficacy and safety of a biosimilar is equal to the reference product.

Application pulled for biosimilar that treats neutropenia.

Increased use of biosimilars could create sustainable care for multiple chronic diseases.

Utilization of biosimilars has the potential to overhaul cancer treatment.

Humira is currently approved to treat rheumatoid arthritis, inflammatory bowel disease, and psoriasis.

Agency releases guidelines to determine the interchangeability of biosimilars with their reference products.

Guidance intends to help sponsors demonstrate Interchangeability with a reference product.

Requirements will vary based on the nature of the proposed interchangeable product, and may include an evaluation of data and information generated to support a demonstration of a biological product’s biosimilarity.

Biological products will be designated with 4-letter suffixes devoid of meaning.

FDA finalizes guidance for nonproprietary naming of biological products.

Top trends will include changing policies, pursuing value, and improving access to care.

This biosimilar payment model is designed to create a significant financial incentive for physicians to prescribe these drugs.

Alternative payment models for biosimilars and reference products may reduce Part B spending up to 35%.

Novel drug from Pfizer treats moderate to severe rheumatoid arthritis that had an inadequate response to methotrexate monotherapy.

New proposed Humira biosimilar performed well in a clinical trial for rheumatoid arthritis.

Pfizer’s Remicade biosimilar will now be reimbursed by Medicare.

The rule builds on the FDA’s ongoing effort to encourage complete postmarketing safety data on various biologic and device products.

Both combination product applicants and constituent part applicants are required to comply with postmarketing safety reporting rules.