The Good, the Bad, and the (Dawn of) Blockbuster Biologics

July 19, 2018

Where will the next blockbuster drug come from?

Medicines have come a long way since the folklore-based treatments of witch doctors and apothecaries from as far back as the middle ages. The developments that we have seen were due to the constant need to overcome challenges arising from an ever-evolving and increasingly fast-paced world. As societies transformed into more complex concentrations of people and traditions, so did the human health concerns of their immediate environments. It has also been increasingly difficult and less practical to produce drugs synthesized only from chemical sources and processes…just ask the Big Pharmas.

They realized that Biotechnology holds the key to unlocking promising, new drugs in the future due to an abundance of candidates in living organisms that can be used as sources for extracting cells, molecules, or DNA that have the potential to become core components of the next blockbuster drug. There is a need to examine the possibilities and potentialities of biotechnology because it is deeply rooted in research and development (usually congruent with the studies being done by academic institutions clustered in the same area as biotech companies). Major pharmaceutical firms have already reached out to those biotech startups to acquire their R&D capabilities, focusing on biological wellsprings to create viable candidates for drug development.

According to Gary Walsh, a professor and the Chair for Industrial Biotechnology at the University of Limerick, Ireland, in his book Pharmaceutical Biotechnology-Concepts and Applications: the future of pharmaceuticals “lies with protein based therapeutics”. Human ailments with high-prevalence rates, like cancer, are usually treated by therapeutic killing and is achieved by administering chemical drugs, which are systemically administered in order to be effective, albeit toxic. Protein based therapies can help avoid systemic effects by offering a more precise alternative, which makes self-delivering and self-assembling protein drugs achievable. In addition, many biologics are produced through recombinant protein therapies (recombinant DNA technology) i.e., monoclonal antibodies. It is not far-fetched to think that biologics could take over the market, even with the anticipated proliferation of generics and biosimilars.

WHY?

Biosimilars have similar structures and functions, as well as comparable pharmacokinetic and pharmacodynamic properties, to Biologics, but are NOT identical to their reference products. Patients taking them will not always have the same therapeutic response as when they take the original biologics. Deviating from their original treatment plan can, potentially, alter their condition (and not necessarily for the best). Even as the pressure increases for pharmaceutical companies to make healthcare affordable, replacing or substituting biologics with less costly alternatives would not be the most ideal next step if one of the ways by which the efficacy of biosimilars are tested is through indication extrapolation—a controversial concept used by the FDA to approve biosimilars through the projection of data, gathered from a Phase 3 efficacy trial for one sensitive indication, to the rest of the indications for the reference product.

Whether or not pharmaceutical companies will continue to bank on expanding their pipeline for their traditional medicines, it is clear that biotech companies are paving the way for biologics to be recognized as the next big thing in the industry not only to create revenue, but also to improve the quality of pharmaceutical treatments available in the market.

Want to explore this and other current trends further? Why not join the decision-makers and experts in a series of roundtable discussions in the field of biology and medicinal chemistry at the two-day Drug Discovery Strategy Meeting at the Hyatt Regency Airport in San Francisco, California.

Learn more: https://proventainternational.com/medicinal-chemistry-wc-us-2018/registration/delegate-registration/?type=delegate&&vip_access=true

By Paula Mae Coronado
Content Strategist, Proventa International