In this week’s news, India still under FDA scrutiny, UK to abide by EU laws to end of 2020, FDA issues new docs and more…

India’s drug and API suppliers will remain on US FDA radar in 2020 says CRISIL

The Indian pharma product sector will be under US FDA scrutiny this year says rating agency CRISIL.

According to a note issued last week the number of warning letters issued to Indian pharma firms by the US agency in 2019 was more than twice the number issued in 2018.

CRISIL director, Sameer Charania, suggested Indian firms would see US revenue decline. He wrote “With intensifying regulatory scrutiny, sales growth from the US market will drop to 10-11% during fiscals 2020-22, compared with a growth of 16% in fiscal 2019.

“Large players are banking heavily on successful launch of complex generic products – these filings have risen to about 25% of the overall new product pipeline from nearly zero three years ago. A substantial delay in resolution of regulatory issues and/or heightened scrutiny could derail the US growth story.”

However, CRISIL also noted many of the issues flagged by the FDA were less serious than in previous years. The agency said this was due to improved facility upkeep efforts and enhanced manufacturing systems.

UK agrees to abide by EU rules to end of year

The UK has agreed to follow EU rules to end of 2020 while it negotiates future relationship.

Presidents of the European Commission and Council and UK Prime Minister, Alexander Boris de Pfeffel Johnson, signed the withdrawal deal last week.

For pharma, the agreement means companies must stick to EU legal and regulatory rules for medicines. The EMA has issued guidance documents to help manufacturers ensure products are in compliance post-Brexit.

The signing will ease concerns the UK will crash out of the European medicines regulatory network – the system for regulating the safety and efficacy of medicines in Europe – when it leaves the EU.

Whether the UK retains its membership of the network – and hence its access to the wider market – after 2020 remains to be seen. The benefits of doing so where set out last week in the House of Lords by Baroness Brinton.

“If we leave the EMRN we will be leaving a body that constitutes 25% of the global pharmaceutical market to be a stand-alone country that makes up only 3% of that market. Pharmaceutical companies will have to submit separate applications to the MHRA to gain UK marketing rights.

“Evidence shows that countries such as Switzerland, Canada and Australia all receive applications for drug licensing after the EMA, with an average delay of six months. The sad fact is that the UK will not be seen as a priority, and patients will inevitably see delays in accessing new medicines.”

US FDA issues guidance on cancer trials and drug-drug interaction testing

The US FDA has finalised guidance on use of the minimal residual disease biomarker in cancer trials and drug-drug interactions in in vitro studies.

The guidance documents (here and here) are designed to help developers make sure the studies they run will be in line with the agency’s expectations.

FDA seeks AI help

In other news, the FDA has asked for help using AI to identify adverse events.

The FDA issued the call last week, explaining it wants the public to develop algorithms that detection adverse event anomalies using publicly available data.

It wrote “During the life-cycle of FDA regulated products, FDA collects data from a diversity of sources including voluntary reports from healthcare providers and patients.

“While cause and effect are not always conclusive or relevant in these reports, valuable insights into the impact of regulated products on public health have been found in individual reports and in evaluation of reported data.

“This challenge engages data scientists to use evolving data science techniques to identify anomalies that may lead to valuable public health information.

Also in the news

Celltrion says it will build a biosimilar plant in China. According to Bioprocess Insider the firm “a business agreement with the city government of Wuhan and the provincial government of Hubei Province on 20 January 2020.”

A US property magnate want to build a cell and gene therapy hub in Pennsylvania. According to the Inquirer Brian O’Neill plans to develop a $1.1 billion cell and gene therapy manufacturing facility in King of Prussia.

Eli Lilly says it will build a manufacturing facility in North Carolina. The facility will make injectables and delivery devices according to Bioprocess Insider.

CDMO trends

Some developments of note in the contracting sector.

Thermo Fisher Scientific has outlined a growth strategy for its gene therapy business. Thermo said recent acquisition Brammer Bio would be key to the plan, predicting the firm’s revenue would grow 25% a year.

Cognate Bioservices has completed the acquisition of Cobra Biologics.

Alcami has bought Tripharm Services to expand its sterile fill-finish capacity.

Catalent has made a cGMP batch of DM199, DiaMedica’s candidate chronic kidney disease (CKD) treatment. The FDA recently gave DiaMedica the go ahead to start Phase II trials of the production.