IMMUNOLOGY

Humira brought in more than $20 billion in 2021 for its manufacturer, AbbVie. Nowseveral 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 optionsin both autoinjector and prefilled syringe forms in an attempt to capture marketshare. These biosimilars provide treatment for various rheumatic and immuneconditions 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-pediatricapproved indications of EYLEA, and submissions to otherregulatory 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 Reporthighlights the correlation between biosimilar marketshare growth and declining average sales prices (ASPs).The report provides an up-to-date perspective on the USbiosimilar industry, showing that biosimilars havegained an average market share of 53% within threeyears post-launch, with a 41% ASP decline over thesame period. The report also indicates that biosimilarcompetition has influenced discounts for varioustreatment categories, with oncology biosimilarsexperiencing the steepest correlation between marketshare 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 betweenIFX products and found that thenumber of switches did notsignificantly affect treatmentpersistence or remission rates.While limitations include the lackof 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 aMassachusetts 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 informationduring the biosimilar approval process that was necessary todetermine whether it infringed Roche patents related tomanufacturing 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 efficacystudies comparing potential biosimilars and reference products, including largeclinical studies of biosimilars with immunogenicity endpoints, are of limited valuegiven the quality control processes in place for all biologics. Additionally, the paperargues that manufacturers and regulators could take greater advantage of existingreal-world evidence instead of requiring comparative pharmacokinetic testing of EUand US reference products.