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News - FDA Issues Draft Guidance on Container Closure Systems and Device Constituents for Biosimilar Combination Products

August 2026 | Paul Bergamini – Events Director, SAE Media Group

The U.S. Food and Drug Administration (FDA) has issued draft guidance intended to help sponsors provide the information needed to develop container closure systems and device constituent parts for biosimilar and interchangeable biosimilar combination products, including prefilled syringes and autoinjector pens. Published on 31 July, the document fulfils a commitment under the third iteration of the Biosimilar User Fee Act (BsUFA III).

Prefilled syringes and autoinjectors are regulated as combination products, and the guidance sets out how the FDA expects sponsors to handle their presentation. The agency stresses that developers must carefully consider the proposed presentation relative to that of the reference product, and that it cannot introduce a condition of use that has not previously been approved, nor a dosage form, strength or route of administration that differs from the reference medicine.

According to the draft, the chemistry, manufacturing and controls (CMC) section of an application should contain a full description of the entire presentation, with complete information on the proposed container closure system and any device constituent parts. That information is expected to cover extractable and leachable studies, performance testing and stability data.

The FDA also outlines three comparative analyses that sponsors should carry out to evaluate differences in user-interface design between a proposed product and its reference: a physical comparison of the device constituent part, a comparative task analysis, and a side-by-side, line-by-line labelling comparison. Data from human factors studies may also be required.

Some design differences may be acceptable. The guidance notes, for example, that an applicant could secure licensure for a biosimilar in a prefilled syringe or autoinjector format even where the reference product is supplied in a vial, provided the biosimilar meets the statutory standards for biosimilarity. However, the FDA will refuse licensure where a design difference results in a clinically meaningful difference in safety, purity or potency, or where it changes the route of administration, dosage form or strength.

For the prefilled syringe sector, the guidance is a clear signal that device presentation is moving to the centre of biosimilar development. As more follow-on biologics reach the market in patient-friendly self-injection formats, expectations around container closure integrity, human factors and comparability with the reference device are likely to shape how quickly these products can be brought to patients.
 

Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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