This was the third VP Conference that I was part of and as before the energy of all the participants refuses to die down. Since I have been trying to learn more about pharma companies, I have tried to work on what are the challenges Indian pharma companies, especially the generic ones, are facing in the US markets since most of the companies we track on VP consider US as their major growth driver. I used to think that I know a bit about pharma sector but I now realise that I don’t even know that since I never thought from the end customer perspective (the retailers) and how the dynamics is changing there until it really hit the sector. We keep on hearing ‘Buyer Consolidation’ in pharma concalls and reports. I have tried to dig a bit on this and present my views on it. Challenges for the Indian Pharma Cos.pdf (970.4 KB)
One question on Complex Generics and opportunity it may provide to companies like Take Solutions (not sure if you are tracking this). You in your presentation mentioned that these complex Generics would require clinical studies. By this you mean clinical trials, like how it is done for NCEs and new drug launches? What would be the extent of clinical trials in comparison to NCEs?
Complex Generics, as per EMA -
"Hybrid medicines,” whose “authorization depends partly on the results of tests on the reference medicine and partly on new data from clinical trials.
Complex Generics, as per USFDA
A complex generic is a generic that could have a complex active ingredient, complex formulation, complex route of delivery, or complex drug device combinations.
I understand that it is much more challenging, a lot more time-consuming and extremely expensive to develop complex generics and demonstrate the equivalence, safety and efficacy of the therapy. This is in comparison to simple generics. But then, how are complex generics different to NCEs in the approval process?
I am trying to size the opportunity here for companies like Take Solutions, and its subsidiaries Navitas, and Ecron (http://www.takesolutions.com/) who provide clinical, safety, regulatory, and consulting services to pharmaceutical companies.
Although, there are clinical trials for complex generics but they are not as extensive (as efficacy is already established for innovators) as that for innovators. The sample size for clinical trials for complex generics is also much small compared to innovator drugs. They are time consuming and costly but still cannot be compared to the research, time and money consumed for getting approval of a new drug in developed markets. Also, approval timelines are much lower compared to innovator drugs.
I think it can be a decent opportunity for a company operating in clinical approval process. However, I have always been put off by Take’s past track record, management actions and its balance sheet.
Quoting from the article:
“One important group of policies is aimed at making it easier to bring generic competition to a category of branded drugs known as complex drugs. Today we’re announcing a major new set of policies to advance these goals.”
