Despite the delays in launching of some biosimilars in regulated markets due to litigations, experts say that biosimilars would be offered at discount of 15 to 30 per cent. This can be substantiated by the fact that Hospira offers Inflectra (infliximab) to French provider at a 45 per cent discount. Orion offers its infliximab biosimilar to a Norwegian provider at 69 per cent discount. Zarxio launches in the US at a discount of 15 per cent.
Though the understanding of the concept of biosimilars by healthcare providers and payers is evolving, intellectual property litigations are slowing its entry into the US. A case in point being of Zarxio (filgrastim) launched by Sandoz on September 3, 2015.
Says David A Dunn, managing consultant, Thomson Reuters Life Sciences and Professional Services, "In March 2015, the US approved Zarxio which was delayed 6 months due to litigation. Amgen had filed lawsuit against Sandoz claiming infringement of a patent covering chemotherapeutic combination. In 2014, Amgen filed a complaint against Sandoz for violation of the terms of the Biologics Price Competition and Innovation Act (BPCIA), or Bio-similars Act. In July of 2014, US federal court extended an injunction barring launch until September 2, 2015. In September 2015, Zarxio was finally launched in the US."
One of the reasons experts also attribute it to that of an evolving regulatory commercialisation framework that differs across geographic regions. Besides the other compelling scenario is that the time required to develop and commercialise a biosimilar product is much longer than that of a small molecule generic.
"Other relevant developments relate to the naming convention based on the guidance documents framed by the USFDA. Non-proprietary Naming of Biological Products – August 2015 defines a non-proprietary naming convention which applies a 4 letter suffix to the core name of a biologic product. Reference biologics and biosimilars will share the core name and be distinguished by the suffix. Among other things, the naming convention will help traceability of the product and hence ensure drug quality. The basis for approval of a biosimilar product depends on structural and functional characterization, animal study data, human PK/PD and clinical immunogenicity, safety and effectiveness data," Dunn added.
In the United States, the FDA has published regulatory guidance documents on the development of biosimilars since 2012; these include guidance on scientific considerations which describes a risk-based “totality-of-the-evidence” approach to evaluate the data and information submitted in support of a determination of biosimilarity. Guidance on quality considerations emphasizes the importance of extensive analytical, physio-chemical and biological characterization in demonstrating that the proposed biosimilar product is highly similar.
Government interventions to boost growth and accessibility of biosimilars is on in other countries like Norway, Sweden and Germany. Cipla and Biocon are exploring emerging markets besides the regulated markets. China is in the process of modeling its regulatory path based on European and US regulations.
Europe led the way in 2005 by setting the first standard pathway for development and approval of biosimilars. Market exclusivity is intended to assure the originator can re-coup its investment and foster future innovation. Current guidelines define analytical standards for proving similarity to the reference product, defined studies in models or humans establishing similar PK/PD, safety and efficacy, regulation of automatic substitution of a biosimilar for the reference product. Proprietary vs. non-proprietary naming conventions impact traceability as well as stakeholder perceptions. Once approved the use of the drug can be extrapolated to the other indications that the reference drug has been approved for.
Other cases of delay in launch of bio-similars due to litigations include Etanercept – Sandoz vs. Amgen/Roche – in which US development ended for this biosimilar in the courtroom when in 2013, Sandoz sought declaratory judgment of invalidity of two key Roche patents on Etanercept. Amgen has extended rights to Etanercept in the US until 2028. Sandoz is still pursuing development in Europe.
Infliximab – Celltrion vs. Janssen is still in the courtroom since 2014. Celltrion has sought declaratory judgment of invalidity concerning three patents owned by Janssen. In March of 2015, Janssen filed suit against Celltrion for violating terms of the BPCIA and patent infringement.