In this week’s news, Switzerland revises biosims rules, US FDA tries to address opioid epidemic, industry eyebrows raised about proposed continuous manufacturing regs and more…
Switzerland rejigs rules on foreign sources biosimilar comparators
Swissmedic has relaxed its biosimilar rules on the use of foreign made comparator drugs.
The new guidance document details how biosimilar developers can use non Swiss reference drugs to prove similarity.
In essence, while Swissmedic would prefer firms to use Swiss-made meds, it will allow the use of drugs from the EU or the US with certain caveats.
Foreign comparators will need to be of identical strength and have the same route of administration to the biosimilar. They will also need to share similar clinical development characteristics.
The regulator said concerns about import quality and issue like Brexit promoted the increase.
FDA mulls packaging rules changes to limit opioid dispensing
The US Food and Drug Administration (FDA) has proposed changes to opioid packaging rules in a bid to address the country’s overdose epidemic.
The regulator wants to require manufacturers to supply 5-, 10- and 15-count blister packs of some immediate release (IR) opioid pain meds.
It said, using fixed-unit packs “would substantially reduce the quantity of opioid analgesics dispensed per prescription.”
The FDA cited research indicating that most patients do not use all the opioids they are prescribed as the basis for its suggestion.
Read the full FDA statement here.
Also read Lachman Consulting’s take on the proposals here.
Industry calls for revision of US FDA guidelines on continuous manufacturing
Drug firms and industry groups have asked the US FDA to revise proposed continuous manufacturing guidelines.
The FDA released its “Quality Considerations for Continuous Manufacturing” in February in a bid to encourage industry adoption of continuous manufacturing processes. The regulator argues that such methods would improve drug quality and help eliminate shortages.
However, the FDA still has work to do to convince industry of the merits of continuous manufacturing according to feedback make public last week.
For example GSK and excipients industry group IPEC-Americas asked how the guidance will relate to the upcoming International Council for Harmonization (ICH) Q13 guidelines.
GSK and fellow drug firm Eli Lilly also called for more information of the scope of the draft guidelines, pointing out that the document does not cover biologics.
Similarly, generics industry group the Association for Accessible Medicines (AAM) warned that continuous manufacturing could have a negative impact on competition due to the costs associated with converting or acquiring facilities and hiring staff.
It wrote that, “There is a risk that these changes could exacerbate rather than alleviate concerns about availability and prices of prescription drugs, if these changes are not handled in a phased manner.”
Also in the news
RAPS reported that Spain’s notified body will no longer accept submissions from medical device developers.
Cannabis companies want the US FDA to relax rules on CBD products according to the New York Times.
The CDC announced that measles cases in the US have surged. The agency wrote about the possibility of eliminating the disease.
Biopharma adoption of single-use technology is accelerating according to an article in GEN. Disposable manufacturing technology is becoming much more commonplace in commercial scale production.
The US FDA discussed the growing US generic drug market in a podcast, available here. The experts looked at market dynamics and globalisation of the generic drug supplier base.
Some developments in the CDMO space
Armas Pharmaceuticals and Micro Labs USA have formed a collaboration to bring select multisource injectable products to the US market.
Private equity fund Ampersand Capital Partners has announced its intention to by CDMO Vibalogics GmbH.
Masy Bioservices has announced plans to expand its validation services operations in North Carolina.
Thermo Fisher Scientific and Scinogy have teamed up to offer a range of cell and gene therapy development services.