In this week’s news: US FDA plans to accelerate biosimilar sup reviews; US concerned about Dutch compounding; and more…
US FDA wants to speed up supplementary biosimilar approval reviews
The US FDA wants to make biosimilar supplement reviews faster.
The agency outlined its plan in draft guidance last week. Supplements are used to update approvals to, for example, allow a product to be used to treat more diseases.
At present the US FDA has a 10 month target for such reviews.
However, according to the new plan the agency “intends that a supplement to a licensed 351(k) BLA seeking licensure of the biosimilar or interchangeable product for an additional condition of use that has been previously licensed for the reference product will be reviewed and acted upon in a 6-month time frame.”
US concerned about Dutch compounding plans
The US embassy in the Netherlands says Dutch rules on compounding may undermine intellectual property rights for drugs,
Last year the Dutch Government introduced laws allowing pharmacists to compound IP-protected drugs. The
According to a statement by the last week US Embassy the scheme is due to be extended, which it says will weaken IP.
“We understand the Dutch government plans to implement policies to expand compulsory licensing and compounding of pharmaceuticals. Such policies send a clear message to companies that IPR in the Netherlands can be undermined or circumvented for short-term financial benefits.
“Such regulatory change could allow patented medicines to simply be replaced by a cheaper, non-patented copy. Apart from IPR problems, this could pose unnecessary risks to public health.”
MHRA freezes pharma fees at 2016 levels
The UK MHRA will keep fees for pharmaceutical firms at current levels.
The Regulator announced the move last week. The MHRA last revised its fee structure in 2016.
According to its most recent accounts, the agency generated a surplus of £25.8 million, last year, an increase on the £13.8 million it earned in 2018.
EMA takes formal possession of new HQ
The EMA held a flag raising ceremony at its new HQ in Amsterdam last week.
The event marked the agency’s move to its base in a tailor-made new building, in the Zuidas area of Amsterdam.
Since the EMA relocated from London to the Dutch capital in 2019, it has operated out a temporary base in the city’s Sloterdijk district.
Also in the news
Celltrion has pulled its team out of Wuhan, China according to Bioprocess Insider. The firm remains committed to building a biosimilars plant but is monitoring the outbreak of the 2019-nCOv.
DCAT looked at the impact Brexit will have on the UK pharmaceutical industry after the end of the transition period in December. The article covers the ABPI’s concerns.
US politicians have voiced concerns about the outbreak of the 2019-nCov virus in China will impact the supply of finished pharmaceuticals and APIs in the US.
According to RAPS several members of the US Senate have expressed concerns about the US FDA’s ability to monitor manufacturing in China.
Fierce Pharma reported that GSK is cutting 720 jobs at its vaccine manufacturing facility in Belgium. According to the article the UK drug firm will expand use of automated manufacturing technology at the facility.
Some development of note in the contracting sector.
Velesco Pharma has started operations at its cGMP clinical manufacturing facility in Wixom, Michigan. See press release.
Catalent will pay $315m for cell and gene therapy CDMO Masthercell Global Inc. See press statement.
Lsne has expanded vial filling and freeze drying capacity at its facility in Bedford, New Hampshire. See release.
Pain drug firm JanOne has hired CoreRx to make TV1001SR, a treatment for Peripheral Artery Disease (PAD), for Phase IIb trials. See press release.