Gastroenterology

At the European Crohn’s and Colitis Organisation congress, Celltrion Healthcare shared positive safety and efficacy data on maintenance therapy including its infliximab biobetter allowing for subcutaneous administration, Remsima SC.

On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.

As a new wave of biosimilars to treat inflammatory bowel disease— an umbrella term for Crohn disease and ulcerative colitis—enter the US market, a lot of clinical and policy news regarding adalimumab and infliximab biosimilars emerged throughout the month of February.

Patients with rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) have similar positive attitudes towards biologics and both trust their specialists’ recommendations, according to a recent survey conducted in Australia.

In Cardinal Health’s 2023 Biosimilars Report, more than 60% of surveyed providers said they would only want to prescribe adalimumab biosimilars with interchangeability designations, suggesting the label may have a greater impact on uptake than originally expected.

Fresenius Kabi announced a global partnership with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.

Formycon shared positive data on its Eylea (aflibercept) biosimilar; Sandoz received a thumbs up from the European Union’s Committee for Medicinal Products for Human Use (CHMP); and Shanghai Henlius Biotech began a phase 1 study for its daratumumab biosimilar candidate.

Vizient’s Pharmacy Market Outlook report examined the impact that factors, such as the COVID-19 pandemic and the US market introduction of adalimumab biosimilars, will have on drug prices and the utilization of lower-cost biologics.

Amgen’s Amjevita (adalimumab-atto) has officially entered the US market, making it the first of potentially 10 biosimilars referencing Humira to launch in 2023.

Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.

Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.

Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).

Health Canada has approved the high-concentration version of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.

A study assessing the use of tumor necrosis factor (TNF) alpha inhibitor biosimilars in France found that the biosimilar penetration rate was higher for infliximab compared to etanercept and adalimumab. The authors said they aimed to understand the key drivers for biosimilar use to improve biosimilar uptake in France.

Janssen filed a lawsuit against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

Fresenius Kabi announced the FDA approval of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.

Following their initial European launch of the drug, Alvotech and STADA Arzneimittel launch their adalimumab biosimilar referencing Humira in 7 more European countries: Belgium, Bulgaria, Croatia, the Czech Republic, Latvia, Romania, and Slovenia.

Iceland-based Alvotech received regulatory approval for AVT02, its biosimilar referencing Humira (adalimumab), from the Therapeutic Goods Administration of Australia.

If every adalimumab biosimilar had an interchangeability designation, the United States could save additional $765 million annually, according to calculations from 3 biosimilar experts.

As the US awaits the 2023 launch of adalimumab biosimilars, Biogen announces an injunction against Sandoz over a natalizumab biosimilar, Rani Therapeutics initiates a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions begins a phase 3 trial for a secukinumab biosimilar.

A report from IQVIA recapped the US experience with Semglee, an insulin glargine biosimilar that has versions with and without an interchangeability designation, to help predict the adoption patterns of adalimumab biosimilars when they enter the market in 2023.

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

Part 5 available now! Paul Reider, MBA, chief commercial officer at Coherus Biosciences, chronicles why Coherus got an interchangeable designation for its ophthalmology biosimilar, how it plans to set its adalimumab biosimilar apart from the rest, and when the pegfilgrastim market could see a competitor for Neulasta Onpro.

The final part of this 4-part series assesses what payers should know about the US introduction of adalimumab biosimilars coming in 2023 as well as policy consideration they can implement to reap the benefits of biosimilar savings.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, chronicles how drug prices as a result of biosimilar competition has evolved over time and what factors may contribute the most to price erosion.

In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.

The third installment of this 4-part series dives into how providers, administrators, nurses, and pharmacists can prepare for adalimumab biosimilars and what role they can play in patient acceptance and use of biosimilars.

The second part of this 4-part series looks at what patients and employers can expect when adalimumab biosimilars hit the market.

Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

In the first article of a 4-part series, The Center for Biosimilars® offers specifics for each of the adalimumab biosimilar products coming in 2023 and explains why the experience in Europe may differ from what’s coming in the United States.