Alvotech

In 2024, the FDA approved 17 Biologic License Applications, including groundbreaking treatments for cancer and genetic diseases, and 18 biosimilars. The Inflation Reduction Act's Medicare Drug Price Negotiation Program set reduced prices for 10 drugs. The FTC released an interim report on PBMs' impact on drug access and affordability. FDA issued guidances on biosimilar manufacturing changes, interchangeability, and promotional communications.

The article highlights FDA approvals of biosimilars, including Amgen’s Pavblu™, BKEMV, and Wezlana™, alongside updates on biosimilar developments and litigation trends. It also covers significant biosimilar market developments and legal rulings affecting biosimilar competition and patent disputes.

The article highlights recent FDA approvals of biosimilars, including Amgen’s Pavblu™, BKEMV, Wezlana™, and RIABNI™, alongside updates on biosimilar developments and litigation trends. It also mentions the FDA’s advisory panel recommendations and the ongoing evolution of the U.S. biosimilar market.

Ustekinumab, marketed under various brand names including Stelara and biosimilars like Wezlana, treats plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis by inhibiting IL-12 and IL-23 to reduce inflammation. It's administered via injection or infusion, with dosage and frequency depending on the condition. Side effects include infections and allergic reactions. It's not for use in children under 6 or those with certain conditions like active TB. Always consult a healthcare provider for personal medical advice.

EU biosimilar filings, CHMP opinions, and authorizations detailed. Legal issues slow guidance; industry seeks transparency. High biosimilarity standards may render interchangeability designation unnecessary. Alvotech petitions FDA against certain Stelara biosimilars. Inflation impacts FY 2025 user fee targets. Sandoz faces lawsuit post-Enzeevu approval. Facility inspection issues rise in biologics licensing. FDA adjusts PDUFA fees, impacting GDUFA and BsUFA. Product-specific guidances influence biosimilar decisions. Switching studies' importance debated. Off-patent associations aim to secure supply. Lytenava's INN confirmed. MPP addresses monoclonal antibody equity. FDA's clinical trial diversity plans monitored. SPC manufacturing waiver concerns raised. New guidance may reduce need for switching studies.

FDA-approved biosimilars for IBD and inflammatory diseases, launching in 2025, aim to improve access, reduce costs, and expand treatment options.

In 2024, significant biosimilar approvals included Wezlana and Uzpurvo for Stelara, Simlandi for Humira, Wyost/Jubbonti for Xgeva/Prolia, and Yesafili/Opuviz for Eylea, all with interchangeability designations, enhancing treatment access and options.

Legal developments in biosimilars for 2024 highlight the balance between innovation, access, and regulation. Key cases include Regeneron's appeal against Amgen's biosimilar launch, J&J facing an ERISA lawsuit, insights on reducing biosimilar legal battles, the impact of the Hatch-Waxman Act, and the role of patents in market delays.

Alvotech announced its inclusion in the Nasdaq Biotechnology Index, effective December 23, 2024, enhancing visibility and attracting investment. The company focuses on biosimilar medicines, aiming to lead the biosimilar space with high-quality, cost-effective products and strategic partnerships.

Alvotech announced its stock will be added to the Nasdaq Biotechnology Index on Dec 23, 2024, enhancing visibility and credibility. The company focuses on biosimilars, addressing cost-effective healthcare needs, with strategic partnerships providing a global presence. However, regulatory challenges and market competition pose risks.