Year in Review: Top Five Foreign Market Developments of 2016

Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2016:

5. Various guidance documents have been published this year further defining regulatory requirements for biosimilars.  The World Health Organization (WHO) proposed a naming convention for biological active substances.  Specifically, the WHO proposed introducing a Biological Qualifier, or a code consisting of four random lower-case consonants, that will be unique to each source of a biological active substance.  Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs, conforming nomenclature to that of the U.S. FDA and the European Medicines Agency.  In late March, India’s Central Drugs Standard Control Organization (CDSCO) published Proposed Revised Guidelines on Similar Biologics (2016), offering guidance on the regulatory requirements for biosimilars in India.  Importantly, there are many differences among biosimilar regulations internationally.  For instance, in Canada, biosimilars are regulated as new biologics as opposed to the U.S.’s abbreviated pathways under the BPCIA.  Additionally, European regulators described the EMA’s biosimilar guidances as “living documents” that are subject to regular revision.

4. The foreign biosimilars market is growing exponentially, and creating fierce competition for branded products, despite the fact that biosimilar uptake is relatively slow.  For example, we reported here that the Indian biosimilars market may reach $40 billion by 2030, and here that South Korea’s biosimilars market will grow to 150 billion won (~$130 million) by 2019.  We also reported that the EMA is planning to launch a pilot program aimed at testing the value of tailored scientific advice for the development of biosimilars medicine.  Doctors and organizations are even fighting for more funding for biosimilar review.

3. Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) announced that Brenzys, an etanercept biosimilar, “could be marked as equivalent” to the branded antibody Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS).

2.  The European Union (EU) approved its 23rd biosimilar product, Samsung Bioepis’s Infliximab, as of May 2016.  The Committee for Medicinal Products for Human Use (CHMP) suggested approval for at least 3 more: (1) Lusduna (insulin glargine), Merck Sharpe and Dohme’s biosimilar to Sanofi’s Lantus for the treatment of diabetes; (2) Movymia (teriparatide), STADA Arzneimittle AG’s biosimilar to Lilly’s Forteo for the treatment of osteoporosis; and (3) Terrosa (teriparatide), Gideon Richter plc’s biosimilar to Forteo.

1. Opposition to the Trans-Pacific Partnership grew throughout the year.  The President-Elect plans to issue a notification of intent to withdraw from TPP, an international agreement that the Senate stated it would not vote on this year.

Stay tuned to the Big Molecule Watch for further developments in the world of biosimilars.