Biosimilars or Generics? A Question of Morality

Pharmaceuticals have always been under the lens with regards to morality. The prime accusation is of considering pharmaceutical or drug industry as a profit oriented business. Conducting simultaneous clinical trials of safety and efficacy, limiting the clinical trials period from the standard and marketing the drug even after failing the safety standards are few blunders done by pharmaceuticals just to have first mover advantages to out beat the competitor.

The subject of concern is, is it about profits and winning or care and safety?

Now a days, a strong new wave of ''biosimilars'' is encroaching the shore of pharmaceutical offerings. Biosimilars or 'follow-on' biologics are biological products that are similar, but not identical, to an innovator product that is already marketed and whose patent has typically expired. Whereas, generics are identical and equivalent to the innovator product.

When it comes to approvals, the biosimilars get quick ''clean chit'' just after cross checking the clinical records with that of reference or parent product. But in the case of generics, they have to cover longer paths and pass every hurdle of clinical trials and emerge spot less. Hence, it can be said that it is easy to get approval for biosimilars than the generic drugs.

Now let's put light on the efficiency and effectiveness of both. A major concern with biosimilar drugs is immunogenicity. As these products are often manufactured in living cells (for example hamster, rabbit or bacterial cells), they are considered foreign by the human body and induce immune responses such as neutralizing antibodies. Immunogenicity can be affected by various factors including manufacturing processes and impurities. Impurities may derive from chemicals or antibiotics used during production or from microbial or viral contamination. These can compromise the purity of the final protein and may alter its structure or properties. Generics on the other hand show slight to no variation in regards to effectiveness and are quite accurate in their results.

Analytical tests can characterise molecular mass, protein content, glycosylation pattern, in vitro activity, physicochemical integrity, stability, impurities and additives of a biosimilar product. However, these analyses will not guarantee equivalent efficacy and safety to the innovator drug in the relevant patient population.

This brings to the fore, biosimilars have tendencies to induce a adverse immune response and at times may not even give desired cure result because of the alteration caused by them on the antibodies. Then why not to stick to the generic identical version of original drug which gives desired results than going for biosimilars?

The Global market for Biosimilars is expected to reach $28,200 million by the end of 2020 growing at a CAGR of around 40%

The key advantage of biosimilars is that they cost 20-25% less than the originator product due to reduced clinical trials

Many established players are trying their best to capitalize on this trend and fetch at most possible benefits.

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