Elephant cartoon

Business Planning & Consulting

How Similar are Biosimilars? Need succeeds over Logic

June 22nd, 2016 - 0 Comments

Is it possible in near future to obtain identical biomolecules?

The answer would be “NO

Consider the below cartoon depicting a monoclonal antibody (mAb) belonging to IgG class.

  1. There are six different known post translational modifications (shaded in grey) which can occur at multiple sites in the protein
  2. At one site, two forms viz. truncated or non-truncated can exist
  3. Therefore, total number of variable forms possible are 26 (64)

However, in most cases the number of sites and the number of modifications is far more and hence the possible number of variable forms is humungous i.e. Xn

X = number of forms per site

n = the number of sites undergoing some form of post translational modification

Therefore, achieving the same form of the antibody by random sampling with a probability of occurrence as 1/Xn is almost impossible.

Picture1

Agreeing to Disagree: What is the solution?

Currently, biosimilars are the best option addressing the affordability issue predominant globally. The future research should satisfy the needs of patients rather than covering up the vulnerable spots resulted out of profit oriented approach by the pharmaceutical companies.

The real success of biosimilars lies in not just striving to establish “similarity” with the innovator product which is near impossible but in achieving the set therapeutic goals.

The fingerprint like technologies could be a solution to identify a protein and demonstrate similarity between a biosimilar and a comparator. It employs fingerprint-like analysis algorithm to compare differences in the quality attributes of the proposed protein product. The obtained fingerprint of a biosimilar is compared with reference product’s fingerprint hence enabling a better match.

Picture1 (2)

We need sophisticated analytical tools capable of precise measurements with high confidence. The bias should be eliminated in inferring the similarity based on “Structure” centric investigations. Novel comparability studies should to be constructed to demonstrate the desired level of sensitivity and accuracy from a patients’ need perspective.

Amidst the debate over a lot of issues like interchangeability, substitution and overall quality of biosimilars, the mAb versions were approved and launched in most parts of the world. The pharmaceutical companies which launched biosimilar mAbs have already initiated observational studies aimed at enhancing stakeholders’ acceptance. The emergence of real world data in future and patients’ experience will further strengthen their cause for existence. This instance would serve as a benchmark where the need for affordable medication drives the research outcomes rather than debating on dissimilarities and its related aspects.

 

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