Skylar Jeremias

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, explained the initial experience gastroenterologists have had with anti–tumor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space.

Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

Tofidence, a tocilizumab biosimilar developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

A recent webinar featured an in-depth discussion on the impacts that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.

September was graced with several regulatory updates from around the world, including some European and Japanese approvals, as well as the FDA’s 2-day workshop on the current science behind clinical efficacy testing for biosimilars and streamlining biosimilar development.

With the European Commission's (EC) approval of Tyruko, Europe receives its first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS), while Coherus Biosciences received a complete response letter (CRL) for its biosimilar for Neulasta Onpro.

Patients with inflammatory bowel disease who underwent a switch from reference infliximab to a biosimilar and then back to the originator were more likely to discontinue their treatment than patients who underwent a single switch from the originator to a biosimilar.

Iceland-based Alvotech announced the approval of its ustekinumab biosimilar referencing Stelara in Japan for autoimmune conditions. The company also released an update on the US filing for its adalimumab biosimilar.

The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.

A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.

Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.

On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.

An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.

A report from the Association for Accessible Medicines (AAM) highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.

An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.

CVS Health Corporation launched Cordavis, a new subsidiary that will work with manufacturers to commercialize and coproduce biosimilars, beginning with an adalimumab product.

Alvotech’s revenues for the first 6 months of 2023 reached $22.7 million, a nearly 600% year-over-year increase.

After a busy July, August brought hope for the biosimilars industry’s future, with the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and several analyses about the health of the market.

Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, shares her reaction to the FDA approval of Tyruko (natalizumab-sztn), the first biosimilar approved to treat multiple sclerosis (MS).

A meta-analysis and systematic review of data on over 10,000 patients with rheumatoid arthritis (RA) found that etanercept, adalimumab, and infliximab biosimilars were clinically equivalent to their reference products.

The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, published her opinions on the future of biosimilars in the United States, foreshadowing immense growth and a transformation of the US health care industry thanks to biosimilars.

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.

Here are the top 5 biosimilar articles for the week of August 14, 2023.

In Biocon’s latest quarterly earnings report, the company revealed that sales for its biosimilars portfolio rose 106% compared with the same time frame the year prior.

In STADA Arzneimittel’s first half of 2023 earnings report, the company disclosed double-digit growth, suggesting that it could see profits hit an all-time high by the end of the year.

The Spanish Psoriasis Working Group updated its position on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.

A Chinese study proved that combination therapy with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.