On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the...
Pharmaceutical consulting and generic drug professionals: What is your hedge against the financial risk associated with increasingly crowded traditional drug markets?
Many generic companies are turning to complex drugs, 505(b)(2) development, and even biosimilars. As you are probably aware, biosimilars are to biologics, what generics are to brand-name drugs.
However, there are major differences between the two. Conventional generic drugs (aka small molecules) comprised of pure chemical substances, structures of which may be identically duplicated, thus allowing for demonstration of bioequivalence to their Reference Listed Drugs (RLDs).
Because of their complexities, biosimilars, also known as large molecule drugs, are never structurally identical.
Click here to read more of our article ‘What is a Biosimilar and How Different is it to Develop than a Drug?’
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review...