Mr. Raja Sekhar Vanga is the Vice President – Global Regulatory Affairs at Biocon Biologics Limited. With over 25 years of experience in the Biopharmaceutical Industry, he is a thought leader in regulatory affairs, specializing in the development and global registration of more than ten biosimilar products. He has successfully navigated complex regulatory landscapes to secure approvals for multiple biosimilar products across all the advanced markets and more than 100 emerging markets. Notable achievements include the U.S. FDA approvals of Ogivri® (first biosimilar trastuzumab), Fulphila® (first biosimilar PEG-filgrastim), Semglee® (first interchangeable biosimilar insulin glargine) and Yesafili (first interchangeable Aflibercept), as well as the pioneering approval of biosimilar insulin glargine in Japan—the first by an Indian company. More recent successes also include Yesintek (Ustekinumab), Kirsty (first interchangeable Insulin Aspart) and Bosaya/Aukelso (Denosumab).

Mr. Raja Sekhar has played a pivotal role in driving regulatory harmonization and engaging with global agencies such as the US FDA, EMA, PMDA, MHRA, ANVISA, NPRA, SFDA, and WHO, fostering alignment to facilitate market access.

Additionally, Mr. Raja Sekhar orchestrated the seamless integration of Viatris’ biosimilars business into Biocon, successfully transitioning over 400 product registrations globally within a 12-month period while ensuring continuity of product supply and operational efficiency.

As a key contributor to Biocon’s success in the biosimilars space, he led the regulatory team behind the company’s landmark achievements worldwide in advancing biosimilar programs, improving patient access to affordable biologics.