IMMUNOLOGY

Humira brought in more than $20 billion in 2021 for its manufacturer, AbbVie. Now several adalimumab biosimilars, Cyltezo (Boehringer Ingelheim), Yusimry(Coherus), Hadlima (Organon-Samsung Bioepis),  Hyrimoz (Sandoz), Hulio (Biocon),Abrilada (Pfizer), and Yuflyma (Celltrion) have entered the market, offering options in both autoinjector and prefilled syringe forms in an attempt to capture market share. These biosimilars provide treatment for various rheumatic and immune conditions and mark the first adalimumab biosimilars since Amjevita's (Amgen)launch in January 2023.

OPTHALMOLOGY

Formycon AG and Celltrion Inc. have both submittedaBLAs for their respective aflibercept (Regeneron'sEYLEA) biosimilar candidates to the FDA. A decision onacceptance is expected within 60 days of June 29 forFormycon's biosimilar candidate, FYB203. Celltrion's CTP42 seeks approval for the full range of non-pediatric approved indications of EYLEA, and submissions to other regulatory authorities are forthcoming. Regeneron'sexclusive rights to EYLEA in the US expire in May 2024and its patents in Europe expire in November 2025.

MARKET REPORT

Samsung Bioepis' recent Biosimilar Market Report highlights the correlation between biosimilar market share growth and declining average sales prices (ASPs).The report provides an up-to-date perspective on the USbiosimilar industry, showing that biosimilars have gained an average market share of 53% within three years post-launch, with a 41% ASP decline over the same period. The report also indicates that biosimilarcompetition has influenced discounts for various treatment categories, with oncology biosimilarsexperiencing the steepest correlation between market share and ASP discounts.

INFLAMMATORY BOWEL DISEASE

Switching patients withinflammatory bowel disease (IBD)from the original infliximab(Remicade) to biosimilarinfliximab (IFX) is shown to besafe and effective as described ina study published in the UnitedEuropean GastroenterologyJournal. The study evaluated 297IBD patients who underwent one,two, or three switches between IFX products and found that the number of switches did not significantly affect treatmentpersistence or remission rates.While limitations include the lack of a control group and missingdata, the study supportssuccessive switches tobiosimilars

RHEUMATOID  ART

HRITISRoche and its subsidiaries, Genentech and ChugaiPharmaceutical, have filed a lawsuit against Biogen in a Massachusetts federal court, alleging patent infringementover Biogen's proposed biosimilar version (BIIB800) ofRoche's rheumatoid arthritis drug, Actemra. Roche's lawsuitclaims that Biogen failed to provide detailed information during the biosimilar approval process that was necessary to determine whether it infringed Roche patents related to manufacturing this drug.

MARKET ASSESSMENT

An opinion piece published in BioDrugs discusses the need to streamline the process of developing and marketing biosimilars without compromising their quality, safety, or efficacy. This will allow patients to have greater access to biological therapies in underserved markets. In clinical trials for biosimilars, clinical efficacy endpoints have been shown to be less sensitive measures of biosimilarity than biochemical, biophysical,and biological functional assays. The authors noted that additional clinical efficacy studies comparing potential biosimilars and reference products, including large clinical studies of biosimilars with immunogenicity endpoints, are of limited value given the quality control processes in place for all biologics. Additionally, the paperargues that manufacturers and regulators could take greater advantage of existing real-world evidence instead of requiring comparative pharmacokinetic testing of EU and US reference products.