Biosimilars Grow From Strength To Strength

Steven Bradshaw noted that with several patent expiries in 2015 and 2016, there was high expectation that a significant portion of the biologics market would shift to biosimilar use by 2016, especially in the areas of diabetes, rheumatology, and in tendering markets. In the US, the long-awaited draft guidance for biosimilar labelling was finally released.[4] However, the uptake of approved biosimilars was less than modest. Part of the reason for this was the identified knowledge gaps among physicians. In a study conducted between late 2015 and January 2016, 91% of physicians were found to be willing to prescribe biosimilars, but only 45% agreed that such products would be appropriate and safe for their patients’ use.[8] Biosimilars were predicted to “rock the boat” in 2016, but this year was more about building and sustaining the interest and trust in the new products.

 Data from incrowd has shown that more doctors say yes to biosimilars with 84% Anticipate Prescribing Biosimilars in Next 3 Years, up by 14% from 6 months prior. However, level of caution has increased with those Accepting Pharmacy-Level Substitution Dropping From 28% to 17%. More elements are said to be considered in their choice to prescribe them at all.

Among the top 10 most important factors in deciding to prescribe a biosimilar, physicians now are placing greater emphasis on thought leader opinions and professional organization guidelines -- now at 55%, from 46% in February -- as well as patient acceptance of biosimilars, up to 49% from 40%.

Comments from the database illustrated their increased caution. "At this time I would not be amenable to switching a patient from a stable medication without significant data to prove complete compatibility," said one rheumatologist. "I would wait and let other doctors experiment on their patients," said an oncologist

Although, figures relating to physicians who would only prescribe biosimilars if they were forced to do so, or there were specific patient conditions that warranted a move away from the originating biologic – dropped from 26% in February 2016 to 16% in September.

The future continues to look positive for biosimilars . As per a recent report, Global Biosimilars Market contributed an overall revenue of $2,552.0 million in 2014 and is forecast to generate an approximate revenue of $26,551.3 million by 2020, growing at a CAGR of 49.1% from 2015 to 2020.

Low pricing of biosimilars, reliable and timely formulated regulations, ease in developing biosimilar, and a quick approval of the drugs by concerned regulators are key driving factors fostering the growth of the market.

The development, approval and acceptance of biosimilars is predicted to increase in 2017. As of October 2016, the US Food and Drug Administration (FDA) has approved four biosimilars, which are setting up for launch in 2017, and there are several biosimilars still awaiting approval and launch.[1] With the cost of many innovator biologics on the rise, biosimilars will definitely continue to gain traction among payers in the coming year.

In the 2016 Biosimilars Forum[2] survey on doctors, some of the identified knowledge gaps were in:

•   Defining biologics, biosimilarity, biosimilars, interchangeability and pharmacy-level substitution.
•   Understanding the approval and evaluation process of biosimilars.
•   Understanding the safety profile shared between a biosimilar and an originator biologic.

In response to the slow uptake of biosimilars, several biologics companies have provided education or opened discussions about the product. Throughout 2016, patient groups, professional societies, health authorities and think tanks joined the conversations and knowledge sharing, which has fuelled the interest among patients and physicians to try biosimilars.

Governments are also zoning in on the regulatory frameworks to facilitate the biosimilar path-to-market, which is augmenting support for the product’s use. Before the end of 2017, the FDA is set to publish draft guidance on interchangeability considerations of biosimilars and statistical considerations for the analysis of biosimilarity.[3]

 Resources

[1] Pharma iQ (2016) Key pharma & biotech predictions for 2016.   Retrieved from http://www.pharma-iq.com/manufacturing/white-papers/key-pharma-biotech-predictions-for-2016

2 Allen, A. (2016). Clampdown on drug prices will save £88m. Retrieved from https://www.cips.org/supply-management/news/2016/september/clampdown-on-drug-prices-will-save-88m/

3  Sagonowsky, E. (2016).  Top generics players and execs face DOJ investigation, charges: Bloomberg. Retrieved from http://www.fiercepharma.com/pharma/top-generics-players-face-doj-investigation-charges-report

 4 Brennan, Z. (2016). FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling. Retrieved from http://www.raps.org/Regulatory-Focus/News/2016/03/31/24681/FDA-Releases-Long-Awaited-Draft-Guidance-on-Biosimilar-Labeling/#sthash.6uocbNDI.dpuf