Our product portfolio includes generic alternatives to both small-molecule drugs and biologics. It is important to understand the differences between the production and marketing of these classes.
Most small-molecule drugs, for example, those that are used in chemotherapy, are made up of molecules with 20 to 100 atoms each. Generics manufacturers can make exact copies of small-molecule drugs with the same active ingredients, dosage, effects, and side effects as the brand-names.
Biologics are much more complex. These large-molecule drugs can have 50,000 atoms and are derived from living cells. It is impossible to replicate biologics exactly. Instead, manufacturers make biosimilars, which are independently designed to have similar properties as the name-brand biologics, though they are not identical.
The development process for biosimilars is complicated, costly, and constantly evolving. Because they are developed independently from and not identical to originator drugs, in many countries they are considered unique products (not generics) and must undergo rigorous clinical trials and testing to ensure they treat disease effectively and do not create undo side effects.
Across the world, regulators are still refining their approach to the registration of biosimilars (which, in many ways, are originator-generic hybrids), as shown in the USA with passage of the Patient Protection and Affordable Care Act in 2010. This law included provisions—sometimes referred to as the Biologics Price Competition and Innovation Act of 2009—that abbreviate the approval pathway for biosimilars while ensuring that registered biosimilars have no clinically meaningful differences in terms of safety, purity, and potency.
The provisions also require that patients be able to switch to biosimilar versions of drugs with no increased risk.