EU steps closer to generics and biosimilars manufacturing waiver

A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer after lawmakers agreed on draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU. The draft of the so-called supplementary protection certificate (SPC) waiver legislation has been agreed at a committee earlier this month and would allow generics and biosimilars firms to make and store the drugs in Europe for export to countries where patent protection has expired. The SPC waiver only applies for the final six months of the protected period and is designed to ensure branded products are not challenged in Europe while their patents are still valid. The proposal would also allow for the stockpiling of generics and biosimilars intended for the EU market during those six months to promote faster market entry. Products manufactured under an SPC waiver for export will be required to be labeled as for export only. Now that the draft has been agreed it will be passed on to the European Council and Parliament for formal adoption.