Since the biosimilars market is still in its infancy stage, biopharmaceutical companies that are attempting to enter space are encountering a variety of distinct challenges. Global regulations not only remain complicated, but they also continue to evolve and differ across certain regions due to a variety of infrastructural issues. Biosimilars is predicted to be a multi-billion-dollar industry in the next few years, so those biopharmaceutical companies that implement the right commercial strategies will have tremendous opportunities to gain shares of a potentially booming market.
Acquiring BI & BA Talent
Biopharma companies are focusing on landing leaders in Business Intelligence and Business Analytics. Recruiting top talent in BI and BA is critical to the success going forward as the biosimilars market continues to develop and becomes more widely accepted.
Engaging Stakeholders
Patients, physicians, and payers/insurers all need to be engaged in the development pipeline to improve market uptake.
Regulatory Compliance
Manufacturers are encouraged to devise strategic roadmaps to navigate the inconsistent global regulations. This will require collaborating with regulatory and health authorities in markets around the world to ensure that they develop strict guidelines for the approval of biosimilar products, such as by referencing the EMA or WHO standards.
Commercial & Market Access Considerations
Smart companies will dedicate more of their resources toward developing potent market entry strategies. The competition should always be examined prior to entering the market. They also need to ensure speed-to-market without losing the integrity of their clinical evidence. Value-based pricing policies should be established as well.
Streamlined Cohesive Function
Successful companies will be those with the most efficient clinical, commercial, and regulatory thinking strategies. Any timeline and sequence of processes must be compressed, and it’s recommended to embrace any organizational changes as needed.
