In this week’s news, lack of cell and gene therapy capacity in CDMO sector, FDA head quits, EMA takes on greater device role, Swissmedic shares inspection data and more…
Cell and gene therapy capacity still lacking in CDMO sector says study
CDMO cell and gene therapy capacity trails demand according to a study, which suggests “mainstream” contractors focus investments on traditional biopharmaceuticals.
The trend was highlighted in a report in Bioprocessing International in which authors Ronald Rader and Eric Langer from BioPlan Associates looked at shifting capacity utilization in the contracting sector.
They suggested the shortfall reflects “mainstream” CDMOs’ reluctance to invest, explaining the smaller cell and gene therapy specialists that have entered the market to take on the work lack sufficient capacity.
“Many CMOs have started up in recent years, but they are nearly all smaller specialist companies, exemplified by the emergence of more than 100 cellular and gene therapy CMOs.”
Rader and Langer contrasted this with CDMO sector investment in capacity for more established types of biopharmaceuticals.
They wrote that a growing number of CDMOs are buying single-use (SUS) bioreactors in the ≥1,000– 2000-L range to support commercial-scale production of protein and mAb-based therapies.
The authors predicted SUS investment will accelerate, citing “increased demand for access to SUS CMO facilities, with available GMP manufacturing capacity minimally in the 5,000-L ± 3,000-L range.”
US FDA abandons plan to add suffixes to approved biologics
The US FDA has said approved biopharmaceuticals will not be renamed to include suffixes, overturning a plan it outlined in 2017.
Originally the FDA had said adding a four letter suffix “devoid of meaning” to the name of all biologics – including newly approved biologics, biosimilars and previously approved biologics – would help monitoring efforts.
However, the FDA changed its plan in draft guidance last week. According to the agency, its pharmacovigilance aims can be achieved by applying the naming convention to products “at the time they are licensed.”
As a result only the names of new biologics and biosimilars will carry the suffix. This is a concern for industry group, the Biosimilars Forum, which said the ability to differentiate would hold back development of the biosimilar market.
The organisation told the Center for Biosimilars site “it considers the updated draft guidance a direct blow to biosimilars uptake” suggesting “it will lead to a misconception that strict pharmacovigilance applies only to biosimilars.”
Outgoing FDA commissioner Scott Gottlieb sought to address these concerns in a statement last week.
He said renaming products would be costly adding that “if those costs were to be passed on to patients the impact would run directly counter to the goals of access and affordability that underlie the biosimilars program.
He added that, “requiring retrospective names changes would not help advance the interest of effective pharmacovigilance since these products are already generally distinguishable by their proper names.”
US FDA commissioner Scott Gottlieb resigns
Gottlieb’s statement will be one of the last he makes as FDA commissioner. Last week the agency confirmed he will be stepping down in April.
Dr Gottlieb did not explain his decision in his resignation letter – available here thanks to STAT. Instead he focused on agency advances during his tenure.
The move comes as a surprise and is contrary to a tweet Gottlieb published in January in which he stated “I want to be very clear – I’m not leaving. We’ve got a lot important policy we’ll advance this year.”
I’ve heard from friends contacted by an online pharma news pub that’s preparing a story speculating that I’m leaving #FDA. I want to be very clear – I’m not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon pic.twitter.com/0xQuXnSPbo
— Scott Gottlieb, M.D. (@SGottliebFDA) January 3, 2019
EMA: no pharmacovigilance fee change until 2020; greater device oversight
The European Medicines Agency (EMA) will not revise what it charges drug firms for its pharmacovigilance services until next year.
The agency made the statement last week, explaining that post-market drug safety monitoring activities will not be included in a fee revision due to be introduced in April.
The EMA also confirmed it will play a greater role in the oversight of certain devices.
Agency director Guido Rasi wrote “With the ever-increasing pace of innovation and the blurring of traditional boundaries between medicines and devices, it is inevitable for the Agency to assume new responsibilities in regulating complex medicines with a medical device component.
“The big challenge we face is to ensure we have the appropriate expertise and resources to adequately carry out these new tasks,” he added.
Swissmedic starts sharing plant inspection data with EU
Swiss drug regulator Swissmedic is uploading drug and API plant inspection data to the European Union’s public database, EudraGMDP.
The database is designed to ensure the GMP compliance status of manufacturing facilities can be readily verified on-line by all stakeholders, including importers, manufacturers and regulatory authorities.
The EMA wrote that Swissmedic’s use of the database – which began in January – is part of the mutual recognition agreement (MRA) between the EU and Switzerland.
It explained that, “Swissmedic has ‘read and write’ access to the data base and will be entering GMP compliance information on Swiss manufacturers, including those exporting to the EU.
“As a consequence, the regulatory requirement to provide original paper GMP certificates issued by EU or Swiss authorities will be replaced by either the provision of a reference to an entry in EudraGMDP or by means of a downloadable file or printout from the data base” the EMA said.
MHRA updates on no-deal Brexit guidance again
The UK MHRA has updated its Brexit guidance for drug manufacturers, this time adding information on ‘biological standards’ used by such firms.
Also in the news
“Pharma bro” Martin Shkreli continues to run his pharmaceutical company from prison according to the Wall Street Journal.
The executive, whose decision to hike the price of the drug daraprim was the subject of criticism, uses a mobile phone to manage his firm Phoenixus AG, which was previously known at Turing Pharmaceuticals AG.
A second person has been cured of HIV according to a report by STAT. The treatment involved transplanting mutant stem cells that the virus is unable to infect.