In this week’s news EC moves forward with SPC waiver, work starts on EMA HQ, Celltrion resubmits rejected biosimilar, and more…

EC aims to change SPC rules with export waiver

The European Commission has formally proposed a relaxation of IP rules to let generics firms manufacture for export prior to the expiry of the originator product’s Supplementary Protection Certificate (SPC).

The EC proposed the revisions on Monday, explaining the aim is to let Europe’s pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.

It said, “Supplementary Protection Certificates (SPCs) extend patent protection for medicinal products which must undergo lengthy testing and clinical trials prior to obtaining regulatory marketing approval.

“Thanks to the [proposed] waiver, in the future EU-based companies will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed.”

The proposed changes are supported by the generic drug industry. In contrast, the branded drug sector has said the waiver will hamper innovation.

Read the EFPIA statement here.

Work on EMA’s new Amsterdam HQ gets underway

Construction of the EMA’s Amsterdam headquarters started last week.

The European drug regulator is due to leave its current base in London’s Canary Warf ahead of the UK’s withdrawal from the European Union (EU) next year.

The laying of the foundation stone for the new building in the Zuidas area of Amsterdam was marked with a ceremony last Monday.

The agency says it aims to be fully operational in Amsterdam on March 30 2019, although it will be based in a rented premises in the city’s Sloterdijk district as the new HQ will not be completed until later in the year.

Celltrion re-files rejected biosimilars for US FDA review

South Korean biosimilar firm Celltrion has resubmitted CT-P10, a biosimilar version of Rituxan, for US FDA review.

Celltrion announced the resubmission last week, explaining it has “made progress” resolving the manufacturing facility problems that saw the US regulator reject CT-P10 last year.

The FDA rejected the previous CT-P10 filing – submitted in April last year – over concerns about Celltrion’s manufacturing facility in Incheon.

If approved in the US, CT-P10 will be sold in partnership with Teva under an agreement signed in 2016.

Celltion also said plans to resubmit a Herceptin biosimilar called CT-P6 – also made in Incheon and also rejected by the FDA last year – for agency review in due course.

Also in the news

Four ABPI member pharmaceutical firms have agreed to take part in NHS Lothian’s Cancer Data Intelligence (LCDI) project. Read more here.

The Wall Street Journal reports that some experts are starting to question the value of large scale clinical research in the era or personalized medicine.

Merck, which is known as EMD in the US and Canada, has teamed with Solvias to develop a new test for fever-inducing bacterial pyrogens in pharmaceutical materials and products.