Case Assignment Questions
1. Assuming Biocon receives approval for BIOMAb, should it launch the drug immediately or conduct phase 3 trials before launch? Elaborate the various elements of your action plan.
If Biocon receives approval for BIOMAb, the management team will need to carefully consider what the best course of action is moving forward. If the company elects to launch the drug immediately, they will be able to have the first mover advantage, reaching the market before their closest competitor, Erbitux. BIOMAb will also be able to put themselves on the map as they would be the first ever, proprietary drug developed and marked by an Indian firm for Indian patients. The Indian regulatory authorities may also cause a lengthy Phase 3 trial due to their lack of experience with bringing a proprietary drug to market, as evidenced during BIOMAb’s Phase 2 trials. However, even with all of the above listed considerations in mind, Biocon should conduct the phase 3 trials before launching the BIOMAb.
BIOMAb is a superior product to Erbitux, as shown in the 100% response rate when combined with chemo and radiotherapy. There are also fewer side affects, a more patient friendly treatment plan, and BIOMAb will be able to offer the drug at a discounted price. Even if BIOMAb is not able to be the first drug to the market, they will be able to make up for those potential loses in the long run. BIOMAb will be entering this marketplace for the first time, and the company will want to enter the market with as strong of a message as possible. BIOMAb is entering this market for the long run, and overcoming any perceptions of shortcuts, lack of quality, or anything less than cutting edge will last well beyond the life of the BIOMAb product. There are only 300 oncologists in this market Biocon cannot afford to miss.
While awaiting Phase 3 approval, Biocon can roll out its direct sales force, offering its suite of generic oncology drugs. This waiting