Aurobindo Pharma Limited, a global pharmaceutical company, has received marketing authorization from the European Medicines Agency (EMA) for its generic version of Zefylti, a medicine used to treat various blood and lymphatic disorders. Zefylti (Efalizumab) is a humanized monoclonal antibody that is used to treat moderate to severe atopic dermatitis (atopic eczema), also known as eczema, and plaque psoriasis.
According to the company, the marketing authorization is a significant milestone, marking the entry of Aurobindo Pharma into the dermatology segment. The company plans to leverage this product to further strengthen its presence in the EU market. The approval is likely to benefit patients in the region who require effective treatment for their skin conditions.
Zefylti is a biosimilar version of Raptiva, a marketed product of Genentech, part of Roche Group. The generic version of Zefylti is expected to offer cost savings to patients and the healthcare system while maintaining the same level of efficacy and safety as the originator product.
The EMA’s decision is based on Aurobindo Pharma’s comprehensive submission, which provided detailed data on the quality, safety, and efficacy of Zefylti. The company successfully demonstrated bioequivalence with the reference product, thereby meeting the required standards for biosimilarity.
The marketing authorization is valid for three years, during which Aurobindo Pharma will be responsible for supplying the product to the EU market. The company plans to enter into partnerships with pharmaceutical wholesalers and distributors to ensure widespread availability of Zefylti across the region.
This approval is a testament to Aurobindo Pharma’s commitment to delivering high-quality, affordable medicines to patients. The company has an extensive range of generic and specialty products in its pipeline, with a focus on critical care, dermatology, and ophthalmology. With this new approval, Aurobindo Pharma is poised to expand its presence in the EU market and contribute to improving patient outcomes.