Shilpa Medicare’s wholly owned subsidiary, Shilpa Biologicals, has entered into a co-development and supply agreement with ...

Currently, the global biosimilars market includes monoclonal antibody (mAb) biosimilars, insulins, interferons, erythropoietins, filgrastim, somatropin and follicle-stimulating hormone. Of these, the ...

A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the ...

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today that the U ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...

The updated guidance allows originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing. This updated guidance in conjunction with ...

Teva gains exclusive commercialization rights for IV and SC ocrelizumab biosimilar formulations across the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey, pending approvals.

The fastest-growing area of healthcare spending is prescription drugs. Leading the way is an expensive class of medicines called biologics, which commonly cost up to $200,000 annually. There are ...