Biosimilars, which are viewed as supplements for their equivalent biologicals in terms of safety, quality and efficacy (if & when proved), are opined as value gainers in the days to come. An external survey predicts an exceptional surge in demand for these products whose value is expected to rise significantly by 2020. With many high-value petitions of biological products nearing their expiry, biosimilars can prove productive for manufacturers in the current scenario.

To understand the global outlook of biosimilars in terms of market and Regulatory perspectives, let us look at the market and Regulatory scenarios of biosimilars in two of the world’s biggest markets, the United States of America (USA) and Europe.

Biosimilars: Europe

With increased approvals of Biosimilar market authorization applications, Europe demonstrates a favorable environment for biosimilars and it is expected that more products are to join the list by the end of the year. As per the reports, in the last two years, the market has seen a two-fold rise in Biosimilar approvals. The year 2017 said to be a record-setting year for Biosimilar approvals. With the growing demand, the market is also expected to venture into new therapeutic areas and new classes of biologics.

Regulatory Scenario: Amid the market growth, one major change that requires additional focus for Biosimilars in Europe is the Brexit, which is expected to come into effect on March 29, 2019. As the European Union (EU) first introduced the Regulatory pathway for the Biosimilars, making their central authorization valid through all the member states, their validity might be questioned post-Brexit. To evade noncompliance in this ambiguous market conditions, manufacturers may have to look out for possible transitions to align with the Brexit which can be mitigated with an expert opinion

Biosimilars: USA

In 2017, the United States of America (USA) has relatively doubled its Biosimilar approvals. There were five biosimilar approvals recorded in the last year and all of them were of complex blockbuster therapeutic antibodies including first time cancer treatment biosimilars. This is evident from the Food and Drugs Administration (FDA) reports.

Regulatory Scenario: The FDA is eyeing at making the Regulatory process less complicated by lowering the size of studies needed for bio-similarity demonstration. To ensure the same is practiced, FDA has released the final guidance for labeling biosimilar products in July 2018 which showcases how Biosimilars can be labelled in line with that of the Generic models.

Influential Factors of Biosimilar’s Market-Entry

Apart from Regulatory updates, there are other factors that affect a biosimilar’s market-entry in any given region. Understanding them and acting accordingly is the need of the hour for organizations aiming to make a difference at a global level. Some predominant factors are listed below.

  • Competition: With the anticipation of biosimilars’ growing value, established players and new entrants are competing vehemently. So, manufacturers must proceed with increased market vigilance and keep abreast of market trends and Regulatory environment.
  • Go-to-market strategies: Biosimilar markets are evolving and changing. With the increased clinical restrictions, manufacturers must incorporate expert capabilities which should reinforce their competence as an organization.
    • Be agile and bold on decisions to establish a commercial foothold
    • Cleverly place resources and make changes in response to short-term outcomes of market
    • Partner with capable market players to mitigate the risk involved
    • Partner with Regulatory experts in the domain for complaint submissions
  • Cost-effective measures: As revenues are deciding the future of biosimilars, saving on procedural expenses proves optimal for manufacturers. Especially streamlining the approach towards therapeutic equivalence trials (clinical and non-clinical) which account for major share of product development costs will be greatly beneficial for the stakeholders.
  • Market-preparedness: Understanding the markets has become increasingly tough. But with technological support such as analytics, the applicants can walk in with reliable data and predict possibilities effectively, and thus stay prepared and relevant while innovating new products.

With more patented biologics set to expire in near future, releasing biosimilars with better compliance efforts may result in expedited reviews and quick approvals. It is suggested that organizations adopt better Regulatory practices and invest in intelligent Regulatory partnership while they continue to investigate the new therapeutic areas. Be informed and compliant.



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