Alvotech

Alvotech (NASDAQ: ALVO) announced its addition to the Nasdaq Biotechnology Index (NBI), effective December 23, 2024, reflecting its meeting of eligibility requirements including minimum market capitalization and average daily trading volume. The NBI comprises Nasdaq-listed companies classified as Biotechnology or Pharmaceuticals and is calculated using a modified capitalization-weighted methodology.

Zelsuvmi's approval for molluscum contagiosum tops Healio's most-read FDA approvals in dermatology for 2024, with other notable approvals including Xeomin, Klisyri, Zoryve, and more.

The biosimilars market is projected to grow from USD 36.01B in 2024 to USD 114.02B by 2031, at a CAGR of 17.9%. Factors driving growth include rising demand for cost-effective biologics and patent expirations. Key trends include regulatory approvals and new product launches. North America is expected to dominate due to favorable regulations.

Alvotech and Advanz Pharma seek EU approval for golimumab biosimilar; Celltrion gains Korean approval for denosumab biosimilars; Intas partners with Xbrane on nivolumab biosimilar. FDA approves Yesintek, a Stelara biosimilar. SB5 biosimilar effective in treating inflammatory diseases. Veterans prefer shared decision-making in biosimilar switching. Biosimilars' market success leads to price reductions.

Alvotech and Advanz Pharma submitted a European marketing application for a golimumab biosimilar, while Celltrion secured Korean approval for denosumab biosimilars. Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar expected to launch post-Opdivo's patent expiry.

Biocon announced FDA approval of YESINTEK, a biosimilar to J&J’s STELARA®, for treating Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis, and Psoriatic Arthritis. YESINTEK, the sixth ustekinumab biosimilar approved, will be commercialized in the U.S. by February 22, 2025, following a settlement with Janssen.

Big pharma's patent cliff presents a $200 billion opportunity for biosimilar developers, especially with biologics. Five companies—Alvotech, Biocon Biologics, Celltrion, Formycon, and Samsung Bioepis—are highlighted for their biosimilar developments and partnerships, aiming to capitalize on this market shift. The biosimilar market is projected to grow significantly, reaching $150.26 billion by 2033, driven by FDA regulations and demand for affordable treatments.

The FDA approved Biocon Biologics' ustekinumab biosimilar, YESINTEK, for treating Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Another biosimilar, Accord Biopharma's IMULDOSA, was also approved for the same conditions, with both biosimilars demonstrating similarity to reference ustekinumab in clinical data.

Teva Pharmaceutical Industries Limited's TEVA stock declined 10% despite strong Q3 results, driven by underwhelming guidance. The company's branded drugs Austedo and Ajovy are key growth drivers, with expected sales of $1.6 billion and $500 million in 2024, respectively. Teva's generics and biosimilars pipeline is robust, with several launches expected by 2027. The company resolved opioid litigation for $4.25 billion, and its stock valuation is attractive, making it a potential buying opportunity for long-term investors.

Sanofi’s rilzabrutinib and Alvotech/Advanz Pharma’s golimumab (AVT05) are among five new entries on the European Medicines Agency’s latest monthly list of products under review. Both drugs are investigational and unapproved globally.