Earlier this year, in Feb. 2012, FDA issued draft guidance on biosimilar product development, and The Patient Protection and Affordable Care Act, which was signed into law by President Obama on March 23, 2010, amended the Public Health Service Act to create an abbreviated approval pathway -- under section 351(k) -- for biological products that… Continue reading Patent Expirations & Biosimilar Drug Regulations In Pharmaceutical Industry: Regulatory Guidelines in India