In this week’s news, US FDA issues long-awaited biosimilars guidelines, ICH revises clinical trial guide, industry group mulls US track & trace and more…
US FDA issues ‘interchangability’ guidance for biosimilars
Biosimilar drug developers now know how to seek interchangability status after the US FDA issued long-awaited guidance on the subject.
The document outlines the information developers that want their biosimilars to be interchangeable – which means they can be switched for the branded product without a doctor being involved – need to file with the agency.
Although several biosimilar products have been approved in the US, none of them have been deemed to be interchangeable.
In April, ex-FDA chief Scott Gottlieb predicted that interchangeable insulin biosimilar will soon be available.
Industry wants clarification on draft FDA combo drug guidelines
Several drug firms and industry groups have raised concerns about FDA draft guidelines on combination therapies.
The guidelines – which cover combination products’ premarket review principles – were issued for public comment in February.
The responses were mixed. Most welcomed the efforts. However, many comments called for more details on cross-labelled products as well as an FDA commitment to make use of existing safety and efficacy data.
Read more at RAPS.
ICH issues general trial draft guidelines
The ICH has issued a draft version of its revised guidelines for clinical trials.
The document – available here – outlines several critical quality factors that can be used in different types of trials, and also touches on trial designs and data sources.
Industry group proposes governance body for DSCSA
The PDSA has proposed the model for a governing body to oversee adherence to US drug track and trace rules.
According to a blog post by Adents, the pharmaceutical distribution security alliance (PDSA) says it is important all actors in the supply chain need to agree on the technology and business rules between trading partners.
The guideline also encourages sponsors to involve patients early on in the study and protocol design phase.
The authors write that “Involving patients at the early stage of study design is likely to increase trust in the study, facilitate recruitment, and promote adherence, which should continue throughout the duration of the study,”
Also in the news
DCAT made some predictions about the US generic drug market for the rest of the year. Pricing pressures have prompted some firms to change strategy.
Developments in the CDMO space:
Alector has teamed up with Lonza to develop early-phase drug candidates. Harbour BioMed and Chia Tai Pharma have partnered to develop biologics. Wuxi AppTec has bought biometrics services firm Pharmapace.
Politico reported that President Donald Trump has ordered Health and Human Services Secretary Alex Azar to work with Florida authorities to develop a drug import plan for the state.
STAT covered the challenges in selling gene therapies in various markets.
McKinsey looked at what is likely to fuel innovation in biopharmaceutical R&D over the next few years.
Bioprocess Insider reported US FDA plans to help cell and gene therapy firms to develop improved manufacturing methods.
The EMA has launched a social media campaign to highlight its efforts to ensure drugs sold in Europe are safe and effective.