Impact on Biosimilar Medicines

Impact of SPC Manufacturing waiver on BIOSIMILAR COMPANIES in Europe according to European Commission according to the official studies published by the European Commission

European Commission reported:

  • An SPC manufacturing waiver for export AND stockpiling would be “the most effective and simplest option”, Impact Assessment, p. 105.
  • “The EU was a pioneer in the development of regulatory procedures to approve biosimilars […] However, there are clear signs that Europe is now losing its competitive edge as a hub for manufacturing of generics and biosimilars, with trade partners now quickly catching up”, Impact Assessment, p. 7.
  • Originators tend to increasingly manufacture biosimilars and generics outside the Union, and notably in Canada, the USA and Asia”, Impact Assessment, p. 12.
  • “Indeed, all four BRIC countries (Brazil, Russia, India and China) have updated their regulatory rules and are becoming increasingly attractive for investments in biosimilars. Global competition is therefore fierce, requiring the EU to take the steps needed to remain competitive”, Impact Assessment, p. 13.
  •  While the legitimate purpose of an SPC is to prevent the manufacturing for the purpose of marketing of competing products on the EU market when it is in effect, it has two unintended consequences that were not foreseen, namely preventing generics/biosimilars (1) from being manufactured in the EU and exported to third countries (where no legal protection applies) during the EU SPC term, and (2) from being manufactured in the EU (and then stored) early enough to be placed on the EU market immediately from day-1”,  Impact Assessment, p. 15.
  • “The main consequence of the above-mentioned problems is increased relocation and/or outsourcing of the manufacturing of generics/biosimilars outside the EU, and loss of business opportunities inside the Union more generally”, Impact Assessment, p. 19.
  • EC clearly states that being immediately on the market is fundamental in such a competitive sector: “the market for generics and biosimilars is highly competitive with a strong ‘first mover’ effect (i.e. a clear advantage for the first mover) both in the export and EU markets”. Also: “For biosimilars, studies show that in 2016, the first biosimilars to reach the market captured over 70% market share”.  The EC also states that “only the first few generics/biosimilars to enter the market capture a significant market share and are financially viable”, Explanatory Memorandum, p.3.
  • “[T]here is no evidence of illicit diversion resulting from the existence of the ‘Bolar exemption’ in the EU, which itself is a form of manufacturing waiver for clinical trials purposes (and is available during the term of both patents and SPCs”, Impact Assessment, p. 35.
  • The EC notes that, with IP expiries, “over EUR 90 billion of the first generation of blockbuster biologics will become open to biosimilar competition by 2020. This will create huge additional opportunities for growth and jobs”. However, according to the actual proposal, the waiver would presumably “on average, be available from 2025”,Impact Assessment, p. 76.

The European Commission provided NO evidence against but only strong support in its official studies to:

  • Introduce the “EU day-1 launch”
  • Remove anti-competitive, unjustified and unnecessary anti-diversion measures
  • Allow an immediate applicability of the SPC manufacturing waiver


  • for export only
  • with anti-diversion measures
  • applicable only to newly granted SPCs