The Challenges of ...

Biological drugs are a relatively new entry into the world of pharmaceuticals, and although pharma giants have always been supporting and establishing biopharma products for a long time and continue to do so due to the legacy of regulatory knowledge, scale-up support and funds from the sales of non-biopharma products (due to the huge lead time for getting biologics into the market), there is a need for a unique identity and distinct support for Biopharma specific requirements.

Case in point, recently Novartis August 2022 had decided to split the Biosimilar portfolio of Sandoz into a separate strategic wing stating that it was in the best interest of the stakeholders.

There are more complexities in the way operations and how business is carried out and it is not only the manufacturing differences between traditional pharma (synthesis) and biopharma (fermentation) that stand out between the two.

Both chemicals and biologicals have differences in nomenclature e.g. API (Active Pharmaceutical Ingredient) for biologics are called DS (Drug Substances), Comparability of the biosimilars is different from the Bioequivalence of the Generics, quality attributes are different, Potency is different from Activity, PK-PD, regulatory & analytical requirements, so on and so forth that it is not easy to have the same rulings/departments/functions, etc. to take the business to the next level (as did Novartis), they need expertise and different training/mindset to really understand and execute the requirements as per the specific understanding as a lot of things can get lost in 'translation'.

Just as preparing a CTD isn't literature writing, business units and marketing units should also have adequate specialized backgrounds and training to realize the full potential of Biopharma.

The stated opinion is based on the opinion and current understanding/experience of the author.

As a business case in general for companies to be successful in both areas (pharma and biopharma), it is imminent or let's say critical that long-term strategies should be set not only in choosing the right products for the future, but also the right infrastructure, capabilities and the right minds working on them to ensure their ongoing success.

Short-term goals need to be anchored or directed to long-term destinations and should not be used to extend the long-term further.