Response to Opinion on: Four steps for streamlining biosimilars development

Biosimilars/Research | Posted 18/08/2023 post-comment0 Post your comment

In the Opinion article, 'Biosimilars drug development: time for a paradigm shift?' published in GaBI Journal, the authors question the need for what they consider to be the arduous regulatory requirements for approval of biosimilars [1]. In response to this article, Dr Robin Thorpe, Deputy Editor-in-Chief of the journal has published a rebuttal [2], providing insightful counterpoints to the concerns raised by the authors.

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In the response, Dr Thorpe highlights that the significant factor supporting the authors proposals is that, to date, approved biosimilars have been shown to have no efficacy or safety concerns. However, these approvals have primarily been granted to biosimilars that have undergone rigorous regulatory scrutiny and been produced by experienced pharmaceutical companies with ample resources. It is noted that issues have arisen with copy products in developing nations, raising concerns about their quality and safety. Therefore, there is a possibility that relaxing approval requirements for biosimilars could lead to unsatisfactory products.

In addition to this, Dr Thorpe notes that current regulatory guidelines are ‘living’ documents and can exhibit flexibility. This is in contrast to the picture of inflexible, unjustified regulations hindering production of biosimilars that is drawn by the authors.

The Opinion article also calls for ‘one global reference product’. However, Dr Thorpe highlights that there are issues surrounding this such as, who provides the product, who characterizes it, who distributes it and how its stability and sustainability is guaranteed? Instead of this, he suggests that an alternative second approach would not provide the reference product, but nominate a commercially available reference product from one source which could be ‘globally’ adopted. However, he points out that, this second approach suffers from similar problems to the one global reference product approach. In addition, there may be issues with continued availability of reference products and ensuring consistent product characteristics, as commercial products undergo development and change unpredictably over time. 

It is also highlighted that the authors blame over arduous, unnecessary regulatory requirements for apparently poor uptake of biosimilars. However, Dr Thorpe notes that more likely reasons for this are the unfounded suspicion of their quality, efficacy and safety by prescribers and patients; and too little difference between the price of the biosimilar and the originator products.

In conclusion, Dr Thorpe notes that although the regulatory requirements evolve as experience and science progresses, this must be carefully evaluated to ensure that efficacy and safety of products are not compromised. He stresses that any perception that ill-advised, politically/financially-driven pressures to inappropriately lower regulatory standards for their approval could seriously damage the acceptability of biosimilars.

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Four steps for streamlining biosimilars development

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1. Athalye SN, Mittra S, Ranpura AM. Biosimilars drug development: time for a paradigm shift? Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(1):17-22. dot:
2. Thorpe R. Response to the Opinion entitled ‘Biosimilars drug development: time for a paradigm shift?’. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(1):5-6. doi:10.5639/gabij.2023.1201.002

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