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Small molecule drugs have had a 110‐year history of scientific advancement and regulatory and industry evolution. In contrast, the modern biologic industry is relatively nascent. The earliest marketed example of a biologic medicine was only 35 years ago with the approval of the first recombinant therapeutic protein, human insulin. Biologics have enormous potential; yet much of this potential is still largely untapped, in terms of therapeutic spread, medical efficacy, and population access. This potential will gradually be fully realized as biologic technologies are translated into routine treatments, occasionally transformational lifesaving treatments. Within the next 5–10 years, the biologics drug market will undergo a transformational period of rapid evolution and maturation compared with the current biologic drug discovery paradigm and business/financial model:

1 Biologics entering nontraditional biologic disease areas: Biologics are entering therapeutic areas where they have not been present historically, such as asthma, dyslipidaemia, and allergy. They will expand treatment options for patients with these disease indications, many of which are underserved currently. Collectively these are important areas for future biologic drug growth but will also present challenges for market creation and maturation.

2 Disruptive drugs and technologies: The number of novel biologic molecules approved by the EMA and FDA has surged in the past three years. In 2016, 50% of FDA new chemical entity approvals were for biologics. This period of high biologic innovation output will bring biologic drugs that will compete with and expand the current innovator biologic and biosimilars market. New technologies also have the potential to be game changing, both in terms of efficacy and novel technological platforms.

3 Biologic asset revaluation: The biologic drug model, both in pre‐commercialization and commercialization stages is now well understood and proven to be effective. Confidence in the growing role that biologics are playing in the pharmaceutical market is impacting on company acquisition trends.

4 Biosimilars bring value: We are entering a transformative period where the largest selling biologics will soon face biosimilar competition in all major international markets. Legal opinions and regulatory guidelines adopted during this initial phase of patent loss will have lasting impact beyond 2020.

5 Competition and market environment: While previously many new biologics were first‐in‐class to go to market, now many biologics are entering the market competing with other biologics with the same mechanisms of action, increasing the ferocity of market competition. As third‐party payers find they have increasing choice in many therapeutic areas, such as autoimmune diseases, competitive dynamics for biologics increasingly resemble those of mature small molecule drug areas and payers place pressure on prices and discounts.

These five market trends will transform the biologic space in the next five years. Market players with interest in biologics face both challenges and opportunities in this new era; what is clear is that the biologic market will be far more complex and evolve far more rapidly than is the case currently.⁹