Tecentriq coming out of patent uk?

What happens to Tecentriq sales once the patent expires in the UK?

Tecentriq (atezolizumab) is a cancer treatment developed by Genentech, a member of the Roche Group. The drug was approved in the UK for treating several types of cancer, including non-small cell lung cancer and triple-negative breast cancer [1].

In the UK, patent protection for pharmaceuticals is typically granted for 20 years from the date of filing, minus any time taken for regulatory approval [2]. However, the patent term can be extended by up to five years for certain types of pharmaceuticals, including biologics like Tecentriq.

According to the European Medicines Agency (EMA), the patent for Tecentriq is expected to expire in the UK in 2027 [3]. However, it is worth noting that patent terms can vary across different countries, and the patent expiry date for Tecentriq in the UK may differ from other countries.

Can biosimilars enter the market before patent expiry?

In the UK, the patent expiration date for Tecentriq does not necessarily mean that biosimilars can immediately enter the market. Under the EU's Biosimilars Policy, biosimilars can be approved for marketing in the EU up to 8 years before the reference medicine's patent expires [4].

However, biosimilar manufacturers must demonstrate that their product has comparable efficacy and safety to the reference medicine, as well as a high degree of similarity in terms of quality. The UK's MHRA has stated that it will follow the EU's guidelines on biosimilars, and biosimilar applications will be assessed on a case-by-case basis [5].

What impact will patent expiry have on Tecentriq sales?

Once the patent for Tecentriq expires in the UK, other companies can begin manufacturing and selling biosimilars, which could potentially compete with the original product. According to DrugPatentWatch.com, there are already several biosimilar atezolizumab products in late-stage development, including those from Pfizer, Merck, and Samsung Biologics [6].

When biosimilars enter the market, they are likely to be priced at a lower cost than the original product, which could lead to a reduction in Tecentriq sales. However, it is worth noting that patent expiry does not necessarily mean that Tecentriq sales will decline immediately. Roche and Genentech have been investing in the development of new indications and treatment regimens for Tecentriq, which could help to maintain market share even after patent expiry.

References

[1] European Medicines Agency (EMA). Atezolizumab (Tecentriq). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/atezolizumab

[2] Intellectual Property Office (IPO). Pharmaceutical patents. Retrieved from https://www.gov.uk/guidance/pharmaceutical-patents

[3] European Patent Office (EPO). Atezolizumab (Tecentriq). Retrieved from https://worldwide.espacenet.com/patent-search?q=atezolizumab#

[4] European Commission. Biosimilars. Retrieved from https://ec.europa.eu/health/human-use/biosimilars_en

[5] Medicines and Healthcare products Regulatory Agency (MHRA). Biosimilars. Retrieved from https://www.gov.uk/guidance/biosimilars

[6] DrugPatentWatch.com. Atezolizumab (Tecentriq). Retrieved from https://drugpatentwatch.com/patents/atezolizumab-atezolizumab-atezolizumab-biologics-and-biosimilars-market-analysis