Biologics & Biosimilars

Biologics

Biologics, sometimes referred to as large-molecule drugs, are protein-based therapeutics (e.g. monoclonal antibodies) that are produced using unique cell lines, including mammalian cells, yeast, and bacteria.

Unlike small-molecule drugs and corresponding generics that are manufactured via chemical synthesis, biologics undergo essential post- translational modifications when manufactured in living cells.

Protein-based therapeutics

Biologics

Undergo post-translational modifications essential to safety & efficacy

Large molecule drugs

Bioequivalent, but not interchangeable

Not patentable

Lower capital expenditure

Biosimilars

Biosimilars are protein-based therapeutics that are highly similar to and manifest no meaningful clinical differences in comparison with existing reference biologics. Biosimilar products must manifest equivalent structure-function characteristics and must maintain equivalent purity, potency and safety.

In contrast to generic small-molecule drugs, interchangeable biosimilar drug products do not currently exist, predominantly because of the inherent complexity of biological drug products and the necessity for high quality standards for bioequivalence, potency and purity.

Time to develop with existing technologies

  • Biologics
10 -15 years
  • Biosimilars
10 -15 years

Complexity

For both biologics and biosimilars, the inherent complexity and high-quality standards impose a substantial burden on their commercial scale manufacture, as even minor deviations in protein expression, isolation, and purification may lead to differences in the structure, reactivity, stability, and other quality aspects of the end product, causing lot-to-lot variations. Any of these differences has the potential to affect the treatment’s safety, efficacy, and shelf life, and to increase the risk of an unwanted immune system response.
For these reasons, the cost to reliably manufacture these biopharmaceuticals at commercial scale is generally quite high. As biosimilars emerge, the necessity to achieve parity on purity and efficacy at a lower price point is paramount, wherein the necessary cost reductions will be derived from increases to purity, yield and throughput and decreases to footprint, capital expenditure and operational expenditure with respect to the manufacturing line. It is clear that these cost reductions will only be attained through robust process innovations.
Size Aspirin IgG Antibody

21 atoms

 

25,000 atoms

 

Complexity
150
parts
6,000,000
parts