Indian manufacturers actually make several complex cancer therapies under the new compulsory licensing law that are made to my knowledge nowhere else except the US. The original manufacturer refused to launch in India.
(Source: a colleague from another country where the manufacturer also made the drug unavailable asked to have the drugs procured from India)
Edit: the drug was Nexavar by Bayer. The CEO was quoted as saying "No, because we did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product, quite honestly". Recently it seems the Indian courts also allowed export licenses for the drug to other markets where Bayer similarly refused to launch - sadly after the relative of my colleague passed away - at least partially from the delay in procuring the drug.
Could you give an example of what makes complex biologics difficult, is it the actual process or just the fact that IP is not shared easily and the hurdles to get licensing in place.
Because they're produced by biological processes (grow cells that produce the protein and purify it), you don't really have atom level control and replicability of the end product - there's a lot of variability. So, the exact process that it's produced with is regulated and tracked, and there will be IP over that process as well. You can see the impacts of that in how much harder biosimilars are to develop than generics
