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Pharmaceutical Patents in India

Pharmaceutical patents for inventions resulting from combination of previously known active ingredients face higher level of scrutiny from the patent examiner as patent office does not generally allow the patent owners to extend the life of existing patents by filing new patents for substantially same or similar inventions, without any novelty or inventive step (non-obviousness).… Continue reading Pharmaceutical Patents in India

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Biosimilars, Biosimilars and Biologics, Biotechnology Patents, Industry News - Technology, Business and Law, patent attorney india, Patent Lawyer Patent Attorney Consulting, Pharmaceutical Patents

Regulatory Challenges and FDA Approval of Biosimilars – An Overview

Biosimilars are generic versions of biologics, medicinal products with active drug component being made (or derived) from a living organism. It is complicated and cost intensive to manufacture biologics, and hence regulatory approval of biosimilars is very challenging. Originally published here. //storify.com/rdpatentlawyer/fda-approval-of-biosimilars-regulatory-challenges/embed//storify.com/rdpatentlawyer/fda-approval-of-biosimilars-regulatory-challenges.js[View the story "FDA Approval of Biosimilars - Regulatory Challenges" on Storify] About the… Continue reading Regulatory Challenges and FDA Approval of Biosimilars – An Overview