Top 10 Manufacturers in Pegfilgrastim Biosimilar Industry

Pegfilgrastim biosimilars are drugs that are developed to be similar to the reference biologic drug, pegfilgrastim. Pegfilgrastim is a synthetic version of a natural protein called granulocyte colony-stimulating factor (G-CSF). It is used to stimulate the production of white blood cells in patients receiving chemotherapy or undergoing bone marrow transplants. By increasing the number of white blood cells, pegfilgrastim can help prevent infections in cancer patients, who are at higher risk due to their weakened immune systems.

Biosimilars are drugs that are developed to be similar to an already approved reference biologic drug. They are designed to have the same mechanism of action, efficacy, and safety profile as the reference drug. Unlike generic drugs, which are chemically identical to their reference drugs, biosimilars are large and complex molecules that are made from living cells.

The regulatory process for approving biosimilars is different from that of generic drugs. Biosimilars must undergo a rigorous testing and approval process to demonstrate that they are similar to the reference drug. This includes testing for efficacy, safety, and immunogenicity (the ability to cause an immune response). The regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines to ensure that biosimilars meet the same standards for quality, safety, and efficacy as the reference drug.

Pegfilgrastim biosimilars are gaining importance in the global market due to their high efficacy in treating cancer patients, lower costs, and increasing availability.

Here are the top 10 manufacturers in the pegfilgrastim biosimilar market:

Mylan N.V.: Mylan is a global pharmaceutical company that is focused on developing and manufacturing biosimilars. In 2018, Mylan received approval from the FDA for its pegfilgrastim biosimilar product, Fulphila. The company is also working on developing other biosimilar products, including trastuzumab and insulin glargine.

Biocon: Biocon is a leading biopharmaceutical company in India that has a strong presence in the biosimilars market. The company has developed a pegfilgrastim biosimilar product, Fulphila, which was approved by the FDA in 2018. Biocon is also developing biosimilars for other drugs, including trastuzumab, adalimumab, and insulin glargine.

Sandoz International GmbH: Sandoz is a global leader in the development and production of biosimilar products. The company has developed a pegfilgrastim biosimilar product, Ziextenzo, which received approval from the FDA in 2019. Sandoz is also working on developing other biosimilars, including adalimumab and rituximab.

Teva Pharmaceutical Industries Ltd.: Teva is a global pharmaceutical company that has a strong presence in the biosimilars market. The company has developed a pegfilgrastim biosimilar product, Nyvepria, which was approved by the FDA in 2020. Teva is also working on developing biosimilars for other drugs, including trastuzumab and bevacizumab.

Pfizer Inc.: Pfizer is a global pharmaceutical company that has a strong presence in the biosimilars market. The company has developed a pegfilgrastim biosimilar product, Nivestym, which was approved by the FDA in 2018. Pfizer is also working on developing biosimilars for other drugs, including trastuzumab and rituximab.

Coherus Biosciences, Inc.: Coherus is a biotechnology company that is focused on developing biosimilars. The company has developed a pegfilgrastim biosimilar product, Udenyca, which received approval from the FDA in 2018. Coherus is also working on developing biosimilars for other drugs, including adalimumab and ranibizumab.

Samsung Bioepis Co., Ltd.: Samsung Bioepis is a biotechnology company that is focused on developing biosimilar products. The company has developed a pegfilgrastim biosimilar product, Ontruzant, which received approval from the European Commission in 2018. Samsung Bioepis is also working on developing biosimilars for other drugs, including trastuzumab and adalimumab.

Amgen Inc.: Amgen is a global biotechnology company that has a strong presence in the biosimilars market. The company has developed a pegfilgrastim biosimilar product, Nivestym, which was approved by the FDA in 2018. Amgen is also working on developing biosimilars for other drugs, including trastuzumab and bevacizumab.

Hetero Labs Limited: Hetero Labs is a leading Indian pharmaceutical company that is focused on developing biosimilars.

Celltrion - Celltrion's biosimilar CT-P10, which is a biosimilar of another G-CSF drug, has been approved by the EMA and other regulatory agencies.