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WHAT IS A BIOLOGIC?
A biopharmaceutical, also known as a biologic medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semi-synthesised from biological sources.
While biologics have revolutionised therapy of several immune mediated inflammatory diseases (IMIDs) like rheumatoid arthritis, systemic lupus erythematosus, other connective tissue diseases (vasculitis, inflammatory muscle disease, Sjögren’s syndrome), and the spondyloarthropathies (axial spondyloarthropathy, psoriatic arthritis), unfortunately they are so expensive that access to them worldwide is limited.
Of the over 55 million people in SA, approximately 1% are affected by rheumatoid arthritis, 0.5-1% are affected by spondylarthritis, and 0.5% are affected by other autoimmune disease. “That’s a large amount of people, but unfortunately, we have a really low rate of using biologics simply because we’re a resource constrained country. Probably at least 10% of affected patients would benefit from, and really need a biologic,” said Dr Elsa van Duuren. “It’s a large number of patients, probably in excess of 100 000 individuals. At present, only 6 000 of those are on biologics.”
THE ROLE OF BIOSIMILARS
Fortunately, as patents on originators expire, biosimilar development has been occurring. “We don’t talk about generics when it comes to biologics because there are some differences. It’s what the WHO calls a similar biotherapeutic product (SBP), or biosimilar,” explained Dr Van Duuren. Describing them as ‘game changers’ she listed the following potential benefits of biosimilar medicines:
- More options for healthcare providers and patients.
- Access to biologic products earlier in disease process.
- Switch from costly originator versions to biosimilar alternatives.
- Biosimilar use expected to save billions around the world.
CHALLENGES FOR A BIOSIMILAR MEDICINE
Biologic medicines are large complex molecules which may be difficult to fully characterise. The amino acid sequence is expected to be the same and only small differences in the microheterogeneity pattern are acceptable.
Biologicals require highly specialised and controlled manufacturing processes. However, biosimilars manufacturers do not have access to all necessary manufacturing information on the originator product. As a result, minor differences in the manufacturing process may affect the pharmacokinetics, pharmacodynamics, efficacy and/or safety.
EVALUATION OF BIOSIMILARS
As a result, unlike generics, biosimilars have to go through very rigorous testing. Dr Van Duuren explained that Sahpra has given very similar guidance to the WHO guidelines on evaluation of SBPs. Decision making regarding the licensing of SBPs should be based on scientific evidence. The onus is on a manufacturer of a SBP to provide the necessary evidence to support all aspects of an application for licensing. As with any drug development program, the development of a SBP involves a stepwise approach starting with characterisation and evaluation of quality attributes of the product and followed by non-clinical and clinical studies.
“Evidence must be provided that the biosimilar is highly similar to the registered medicine in quality, potency, purity, safety, and efficacy,” said Dr Van Duuren. “So, they go through the same type of clinical studies that the originator product went through – preclinical studies, toxicity studies, phase 2 randomised controlled trials with dose comparisons, and phase 3 double blind randomised controlled trials. The only sort of short-cut that biosimilars are allowed is that they’re allowed to do a study in one indication and extrapolate the efficacy data to another indication.”
“The bottom line is we really have good data to support the use of biosimilars and that’s because they have to go through such vigorous testing and trials. We’re already seeing that biosimilars are going to offer a lot more benefits to a lot more patients.”