Some days back I received an email from some lady and she asked me some question related to biosimilars so I thought of jotting them down in my blog
I. What is some of the current challenges you are experiencing in your industry?
•Manufacturing part: Large investment required due to expensive and sensitive manufacturing process with difficulty in reproducibility of results.
•Huge clinical trial development cost
•Regulatory process till now not clearly defined in regulatory market Europe (EMEA) and United states (FDA)
II. What are the top 3 things that should improve?
According to me the following things should improve for dissimilar in Indian scenario they include
•Better clinical studies prioritization and development with expertise in filing in regulated market
•Comprehensive competitive intelligence or due diligence for the product portfolio with establishment of state of the art manufacturing process
•Consistent portfolio strategy with effective branding and marketing skills.
III.What is upcoming future opportunities that you see in the field of biosimilars?
In accordance to indian scenario the oppurtunities associated with biosimilars include
•Cost saving
•Higher margins and better profitability structure as blockbuster drugs are coming off patent.
PS: The 12 years exclusivity for biopharmaceutical drug in United States I don’t see a good market potential of bio similar in United States in the coming decade as compared to European bio similar approvals.
I could not agree with you more that Indian companies need to understand the competitive landscape especially in highly regulated markets. If we look at the currently approved biosimilars available in Europe and Canada there is not one Indian company on the market. Indian companies are going to have to compete in the regulated market more aggressively to combat the threat of Western companies competing in the lesser regulated markets.
ReplyDeleteBiosimilars is a market opportunity which Indian companies cannot afford to be major players. In order to compete they will need to invest in multiple areas most of which are well recognized, but they must also set aside funding for in-depth market assessment of regulatory and competitive factors.