Guidelines on Similar Biologics

Guidelines on similar biologics: regulatory requirements for marketing authorization in India.

On the Regulatory Approval Pathway of Biosimilar Products

Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval framework for biosimilar products, and WHO has published guidelines on the evaluation of biosimilars ...

Quality, safety and efficacy of follow-on biologics in Japan.

Recently, WHO, EU, Japan and Canada have published guidelines on biosimilar/follow-on biologics. While there seems to be no significant difference in the general concept in these guidelines, the data to be submitted for product approval are partially different. Differences have been noted in the requirements for comparability studies on stability, prerequisites for reference product, or for the...

Analysis of the Regulatory and Reimbursement landscape of Biosimilars

INTRODUCTION A biosimilar is a biological medicine that is developed to be similar to an existing biologic, with the active component of the biosimilar being essentially the same biological substance as its reference product. A wide variety of biosimilars are available, from relatively small molecules such as human insulin or erythropoietin, to complex molecules such as monoclonal antibodies. B...

Use of Biologics and Biosimilars in Rheumatology.

Prior to the availability of biologics, synthetic DMARDs (Disease modifying anti-rheumatic drugs) were the mainstay of the treatment in rheumatology. With the introduction of biologics, the scenario is changing to become more promising. These drugs have innovative mechanism of action, based on the targeted inhibition of specific molecular or cellular targets directly involved in disease pathoge...