In this week’s news, US FDA makes ANDA process more transparent, EC starts trial database audit, study questions 12-year exclusivity for biologics and more…
US plans to make ANDA timelines predictable curb price hikes
The US FDA wants to make generic drug review processes more predictable to help curb price rises.
Acting agency commissioner Ned Sharpless announced the plan last week, explaining that efforts to keep the price of generic medicines low are linked to drug reviews.
“One area we have identified to help spur investment in generic drug development is the availability of resources that may help applicants predict when their application may be able to receive final approval and when they may begin marketing their product ‒ providing patients timelier access to high-quality, lower-cost medicines.
“As a result, today we are enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products.”
The move comes amid concerns that higher generic drug prices are restricting access to drugs in the US.
Read the full statement here.
The comments coincide with the US FDA’s publication of its guidelines for the content and format of ANDA submissions.
Scientists question 12-year exclusivity periods for biologics
A study suggests the 12-year exclusivity periods granted to biologics may not be justified.
The research – published in Nature – looked at the average time taken to move candidate biologics through preclinical studies and clinical trials.
The results suggest that, rather than being longer, the time it takes to trial biologic drugs is comparable to the time taken to test small molecule drugs.
According to the authors, the finding calls into question whether biologics developers deserve 12-year exclusivity periods, rather than the five years granted to small molecule firms.
US FDA releases 20-years of “hidden” device data
The US FDA has made public 20 years of data for medical devices submitted to its now defunct Alternative Summary Reporting (ASR) programme.
The ASR programme was intended to let medical device manufacturers log “specific well-known and well-characterized events associated with specific devices,” according to the FDA.
However, last year Kaiser Health News suggested the ASR programme had allowed some medical device companies to report injuries and malfunctions outside a widely scrutinized public database.
EMA starts trial database audit two years late
The EMA has begun auditing its clinical trials information system.
The CTIS is the portal through which sponsors will submit the results of studies involving people.
“In June 2019, CTIS enters a phase of agile, iterative delivery, to prepare the system for audit. It will then be further enhanced for go-live and beyond, in close cooperation with the user community.
“The Agency and the Member States are fully committed to ensuring the success of this project and its delivery” the EMA wrote.
The agency also said it is working with EU member states and industry to ensure that the system is appropriate.
Originally the EMA predicted that the audit would begin in 2017, however, put back the deadline citing technical difficulties.
Also in the news
CPhI looked at how CDMOs can work with pharmaceutical firms in China.
Bioprocess Insider reported on the complex processes involved in making the gene therapy Zolgensma.
The European Commission has outlined what it will expect from experts keen to get involved in premarket product evaluation consultation procedures under the EU’s devices and in vitro diagnostic regulations. Read the full story at RAPS.
Developments in the CDMO space
Lyophilization services of New England (LSNE) has acquired a sterile injectables facility in Leon Spain.
Catalent has completed the purchase of a manufacturing plant in Italy. The facility was previously owned by Bristol Myers-Squibb.
Thermo Fisher announced that its $100m expansion of Brammer Bio is complete.
Piramal said it plans to invest $10m to expand API capacity.