Drivers and resistors of biosimilars

August 23, 2011 2:42 PM

Are biosimilars well accepted? What do regulators, prescribers, pharmacists or patients think about using a biosimilar?

With the reference of a slide set which was presented at a recent biosimilars conference, let’s have a look at the global picture and see the drivers and resistors of biosimilars:

Economic drivers: The governments/payers have to pay more every each day for medicines and they are trying to control their budgets.

–         Poor economic performance
–         Health budget reduction
–         Development cost containment
–         Biosimilar price around 70-80% from originator
–         Health profit margins

Legal and commercial drivers: Patent expiries is the most critical issue in biosimilar development. Upcoming patent expiries of monoclonal antibodies will boost biosimilar sales in the US and Europe.

–         Patent expiry
–         Uncontested sub-classes of biologics with expired patents (heparins, Enbrel)
–         Co-development and co-promotion opportunities

Clinical drivers:  Although the topic is clinical, the benefits are related to economic policy of biosimilars. Cheaper medicines will be used more widely and this will help more people to see the benefits.

–         Lower costs may allow long-term treatment which can potentially translate in improved survival, QoL and disability outcomes
–         Superior delivery devices
–         Top-down approach (biologics might be increasingly used as initial treatment)

Scientific and regulatory  drivers: 20 years is too much in science and there are lots of developments since the innovation of the current original biologics. Biosimilars have the advantage of this time difference. Besides, regulatory bodies around the world are continuously working on guidelines to make things easier for biosimilar manufacturers.

–         Advances in analytical techniques
–         New trial designs
–         Regulatory experience with approvals and interactions with industry
–         WHO guideline and US biosimilar legislation were enacted recently
–         New EU biosimilar class-specific guidelines
–         Improvement in GxP compliance

Commercial resistors: Biotechnological manufacturing is definitely more difficult and more expensive than a conventional chemical drug. Additionally there are lots of biosimilar players around the world and more to come soon; this will make competition harder.

–         Requires strong manufacturing capabilities
–         Outsourced manufacturing is accompanied with greater risks and uncertainties over price flexibilities
–         Opposition (resistance) from innovators
–         Competition (>150 biosimilar developers globally)
–         Cost of clinical studies can be higher than originally anticipated
–         No experience in branded products
–         No added ‘brand’ specific features allowing to achieve
–         Brand differentiation and preserve market space against competitors

Legal resistors: Lots of innovators are interested in biosimilars business and they try to control this market. Interchangeability, substitution, exclusivity to the first biosimilar etc. are still unclear.

–         Unclear exclusivity and pricing terms
–         Lack of time on the market
–         Threat for biosimilar companies acquired by innovators

Clinical and regulatory resistance: Biosimilars are a fact today but this perception is not the same in every country; we can see the results of this difference in European markets. Additionally originators are developing new biologics to change the treatment regime and this is a threat for biosimilar players.

–         Uncertainity over long-term safety risks
–         Regulatory and pharmacovigilance burden
–         Poor level of understanding from prescribers and patients
–         Lack of regulatory  consistency and globally harmonised approach
–         Potential changes in the treatment paradigm


What do you think? Do you have more to add or something to object?

Please share your comments with us using the form below. We would be pleased to see your contribution on this subject.

Reference: Kudrin A. Biosimilars: Regulatory challenges in extrapolation of new indications: Clinical data requirements and new concepts; Informa Life Sciences’ Biosimilars Conference; 2011 Jun 9; Berlin, Germany.

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