Biosimilar news
Here are some recent news updates on biosimilars:
FDA Approvals
- On March 25, 2023, the FDA approved Amgen's biosimilar to Humira (adalimumab), called Amgevita, for the treatment of several autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, and Crohn's disease.
- On February 22, 2023, the FDA approved Pfizer's biosimilar to Enbrel (etanercept), called Erelzi, for the treatment of several autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis.
Pipeline Updates
- In February 2023, Samsung BioLogics announced that it had completed the Phase III clinical trial for its biosimilar to Herceptin (trastuzumab), which is expected to be filed with the FDA in the second half of 2023.
- In January 2023, Biocon announced that it had completed the Phase III clinical trial for its biosimilar to Rituxan (rituximab), which is expected to be filed with the FDA in the second half of 2023.
Market Trends
- According to a report by ResearchAndMarkets.com, the global biosimilar market is expected to reach $25.6 billion by 2027, growing at a compound annual growth rate (CAGR) of 24.1% from 2020 to 2027.
- A report by Grand View Research estimated that the global biosimilar market size will reach $43.6 billion by 2025, growing at a CAGR of 23.4% from 2020 to 2025.
Regulatory Developments
- In February 2023, the European Medicines Agency (EMA) announced that it had adopted a new guideline on the development and authorization of biosimilars, which aims to provide a more streamlined and efficient process for the development and approval of biosimilars.
- In January 2023, the FDA announced that it had finalized a guidance document on the development and approval of biosimilars, which provides guidance on the scientific and regulatory requirements for the development and approval of biosimilars.
Industry News
- In February 2023, Amgen announced that it had entered into a partnership with Novartis to develop and commercialize a biosimilar to Lucentis (ranibizumab), which is used to treat wet age-related macular degeneration.
- In January 2023, Pfizer announced that it had entered into a partnership with Biocon to develop and commercialize a biosimilar to Humira (adalimumab), which is used to treat several autoimmune diseases.
These are just a few examples of the latest news and developments in the biosimilar industry. If you're interested in staying up-to-date on the latest news and trends in biosimilars, I recommend following reputable sources such as the FDA, EMA, and industry publications.