We are committed to high-quality, urgently needed biosimilars for oncology and inflammatory diseases. Our products will broaden access to biopharmaceuticals, allowing more patients to benefit from scientific advances.
A deep understanding of protein-based therapeutics enables us to conduct efficient biosimilar development programs. They are based on current scientific, regulatory and healthcare market considerations. On the basis of our efficient approach, we are able to develop biosimilars in a manageable and foreseeable time period.
For our first biosimilar Pelmeg®, a biosimilar version of Neulasta® (pegfilgrastim), we have successfully proven this concept. Pelmeg® received marketing authorisation in the EU in November 2018. The clinical program consisted of two head to head trials confirming the biosimilarity of Pelmeg® to Neulasta® for various PK and PD endpoints.
Mundipharma Biologics was created in 2013. With offices in Pamplona, Spain, and Munich, Germany. At Mundipharma Biologics, we conduct biosimilars development and manufacturing exclusively in Europe. We adhere to the highest European quality standards based on strict guidelines and our specialist know-how are the key to our success in the global biosimilars market.
Our team has a proven track record in developing and launching biosimilars and biopharmaceuticals in different indications and international markets. With a thorough understanding of protein-based therapeutics and disease biology, we conduct efficient biosimilar development programs. Our team benefits from the support and experience of the entire Mundipharma network.
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