Biotai Adalimumab injection has obtained approval for marketing in the UK MHRA
Recently, Biotech Biopharma announced that its independently developed adalimumab injection (trade name: Gleli®) has officially obtained the marketing approval of the UK Drug and Health Products Administration (MHRA). This milestone marks the further expansion of Biotech's global biosimilar market and provides more high-quality and affordable treatment options for patients around the world.
1. Event background
Adalimumab is a fully human anti-TNF-α monoclonal antibody. The original drug is Humira® of AbbVie, and is one of the highest-selling drugs in the world. Biotech's Gleli® is the first biosimilar to be approved for marketing in China. It has been approved in many countries and regions such as China, the European Union, the United States and other countries.
2. Approve key data
| project | data |
|---|---|
| Drug name | Adalimumab injection (Galli®) |
| R&D company | Biotech Biopharmaceuticals |
| Approved institution | UK MHRA |
| Approval date | October 2023 (the specific date is not disclosed) |
| Indications | Autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and psoriasis |
| Original drug | Humira® |
III. Market impact analysis
1.Global Market Structure:Shumeira®'s global sales in 2022 are approximately US$21.2 billion, but the patents have expired one after another. The entry of biosimilars will significantly reduce the cost of treatment.
2.Progress in internationalization of Biotech: This approval is another important breakthrough for Biotech in the European market after the EU EMA approval.
| area | Approved status | Approval time |
|---|---|---|
| China | Approved | 2019 |
| EU | Approved | 2022 |
| USA | Application submitted | To be determined |
4. Industry hot topics
The global pharmaceutical industry hotspots in the past 10 days are closely related to this incident:
1.Competition for biosimilars intensifies: With the launch of biosimilars from Amgen and Samsung Bioepis, the global adalimumab market price has dropped by 40%-80%.
2.Changes in UK medical policy: MHRA accelerates the approval of innovative drugs after Brexit, and has approved 37 new drugs (including biosimilars) in 2023, an increase of 15% year-on-year.
5. Future Outlook
Biotech said it plans to promote Gleli® to be listed in more than 10 countries in the next two years. Analysts predict that by 2025, Biota Adalimumab's overseas sales are expected to exceed US$500 million. The UK's approval will lay an important foundation for its entry into the Commonwealth national market.
Conclusion
Biotai Adalimumab injection has been approved by MHRA, which is not only an important achievement in the internationalization of China's biopharmaceuticals, but will also bring more economical treatment plans to patients around the world. With the rapid development of the biosimilar market, it is expected that the global adalimumab market size will be reshuffled in the next three years.
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