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Author: Dr. Amit Sengupta

Abstract: In this paper Dr. Sengupta examines the landscape of biological medicines, and locates this analysis in the characteristics of biological drugs which set them apart from small molecule drugs (SMDs). These characteristics of biological drugs impact on the way these drugs are manufactured; on the development of follow-on versions of innovator biological drugs; on the way biological drugs – both innovators and follow-ons – are regulated; on the way these drugs are protected by different kinds of intellectual property rights (IPRs) and data protection mechanisms; and on the opportunities and challenges in the introduction of biological drugs, including biosimilars, in a range of countries.

The paper concludes with following conclusions and recommendations:

• The potential role of biological drugs in promoting real therapeutic advances needs a deeper analysis. However, current evidence sug- gests that they will play an increasingly major role in the future in advancing therapeutic outcomes for several autoimmune and de- generative diseases and in cancer treatment.

• Biological drugs are extremely expensive. Their high prices are a reflection of protected monopolies in the biotech sector. Further, unlike in the case of SMDs, the anticipated drop in prices after introduction of biosimilars is conventionally pegged at only around 30%. There are no clear technical reasons why price drops cannot be much sharper.

• Regulatory barriers (i.e., onerous requirements for regulatory approval) are key factors preventing introduction of cheaper follow-on products of equivalent safety and efficacy. The current regulatory regimes and the underlying WHO guidelines are not in sync with advances in the science of biological products. Insistence, by regulatory agencies and in the WHO guidelines, on head-to-head comparisons, including comparative pharmacokinetic studies, between innovator products and follow-ons is no longer justifiable. Moreover, it is possible to obviate the need for expensive and difficult-to-design clinical trials given better techniques for characterization of follow-ons, which could be combined with animal studies. Regulatory regimes and guidelines, including the WHO guidelines, need to be revised taking the above into account.

• Given monopolies enjoyed by innovator biologics and their very high market prices, there appears to be little incentive available to reduce the cost of manufacture of biological products through intro- duction of more efficient technologies. On the other hand, the manufacturers of follow-on products appear better placed to introduce more efficient and cheaper technologies.

• Intellectual property protection, just as in the case of SMDs, promotes monopolies and prevents the early introduction of follow-on biologics. Process patents and trade secrets are major barriers to the introduction of biosimilars. In addition, the biotech industry is more aggressive in demanding data exclusivity rules. All these act as layers of barriers to the early introduction of cheaper biosimilars.

• The proposed introduction of ‘Biological Qualifiers’ to be tagged on to INNs for biosimilars is unjustified and WHO should not pursue this proposal.

• It is necessary to harmonize rules and allow for interchangeability between innovator products and biosimilars which have received regulatory approval. This would make uptake of biosimilars in clinical practice easier.

Citation: Amit Sengupta. Biological Drugs – Challenges to Access. Third World Network. October, 2018;

Full paper on the Third World Network Website: English | Spanish