Is Alpelisib produced in India a generic drug?

Alpelisib (Alpelisib), trade namePiqray, is an innovative drug developed and produced by the Swiss pharmaceutical company Novartis Ltd. It is mainly used to treat certain types of advanced breast cancer . As a PI3K inhibitor, Apelvis inhibits the proliferation and growth of cancer cells by inhibiting the PI3K-AKT-mTOR signaling pathway. It is especially effective in breast cancer patients with PIK3CA gene mutations. The Indian version of Apelvis is not a generic version but the genuine version, which is still manufactured by Novartis and has no differences in ingredients and quality with other versions of the drug around the world. Although the packaging, strength and pricing of Apelix may vary in different markets, the drug's basic ingredients and therapeutic effects are consistent.

Compared with drug versions in markets such as Europe and the United States, the Indian version of Apelvis may be more affordable in terms of pricing due to the region where it is produced and sold. This is mainly due to pricing differences caused by different regulations and market demands on pharmaceutical production and sales in India. Particularly in India, drug pricing is often influenced by local production costs, making Apelvis available at lower prices in the Indian market than in some Western countries. This difference also reflects the unique advantages of the Indian market in drug pricing, making treatment affordable for more patients, especially in developing countries.

Although the Indian version of Apelvis is less expensive, it is not a generic version. Generic drugs are usually produced by other companies. They have the same pharmaceutical ingredients as the brand-name drugs, but may have differences in production processes, excipients, and packaging. However, the production and sale of Apelvis in the Indian market remains owned by Novartis, ensuring that the quality control of the drug meets global standards. Therefore, patients can use the Indian version of Apelvis with confidence.

Reference materials:https://www.ncbi.nlm.nih.gov/books/NBK574353/