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Janet Worrell, PhD, FTOPRA MRPharmS
Associate Director, Regulatory Strategy
Janet is a self-energised and forward-thinking regulatory strategist with a passion for innovation and collaboration. A qualified pharmacist with a PhD in medicinal chemistry, Janet brings extensive experience across ethical and OTC medicines, and is a Fellow of the professional body TOPRA.
With a strong track record of developing and implementing pragmatic regulatory strategies, Janet thrives in complex and evolving environments – particularly within the post-Brexit landscape. Her leadership style is grounded in integrity and strategic thinking, enabling her to guide international regulatory and technical teams in delivering innovative products across diverse categories.
Janet is a confident communicator and a natural connector, known for building strong internal and external networks. She enjoys working collaboratively to shape solutions that are both compliant and commercially viable, and is committed to advancing regulatory excellence through thoughtful engagement and shared learning.
Biosimilar Development: Life Beyond Phase 3 Trials
Biosimilars have been an important trend since 2006, a strategic trend since 2015, and a core component of medicines policy since 2018. By 2025, 140 biosimilars were approved in Europe, representing approximately 40 to 50% of EU biologics volume.
What Are Biosimilars?
Biosimilars are biologic therapeutic products that are highly similar to an already approved reference biologic, with no clinically meaningful differences with regard to safety, purity, and potency.
The EMA started to accept PK/PD comparability data in place of Phase III efficacy trials between 2005 and 2006. At that time, the UK and MHRA were part of Europe, pre-Brexit. Together, both agencies developed an approach that allowed approval of biosimilars without Phase III efficacy trials where structural and functional comparability is robust, PK similarity is demonstrated, and a validated PD marker predictive of clinical outcome exists. The approach has been continuously refined and formalised since then.
Post-Brexit, the MHRA continues to champion this viewpoint because EMA guidance was already in place, UK assessors participated directly in CHMP biosimilar evaluations, and the first biosimilar, Omnitrope (2006), was assessed with MHRA involvement. In May 2021, the agency discontinued the requirement for biosimilars to undergo confirmatory efficacy trials as a licensing condition, further consolidating its position.
Several regulatory agencies have now adopted the original thinking of EMA and MHRA:
| Regulatory Agency | Phase III Can Be Waived? | Notes |
|---|---|---|
| EMA | Yes | Global pioneer |
| FDA (US) | Yes | Increasingly common |
| WHO | Yes | Phase III optional |
| MHRA (UK) | Yes | Global pioneer |
| Health Canada | Yes | EMA-aligned |
| PMDA (Japan) | Yes | Case-by-case |
| ANVISA (Brazil) | Yes | Conditional |
| MFDS (Korea) | Yes | Strong alignment |
| NMPA (China) | Yes | Case-by-case |
What Does This Mean for You and Your Portfolio?
You may be asked to provide input to a regulatory strategy for biosimilars without having had prior experience of such a submission, or your company may have acquired a biosimilar in development. The MHRA readily accepts biosimilar marketing authorisation applications on this basis. We have been able to gain direct feedback on this approach through scientific advice and pre-submission meetings in this area.
Through the wider regenold team and our network of trusted partners, regulanet, we are well placed to support all the markets listed as adopters of this approach.
It is estimated that approximately 10% of biologic drugs are expected to lose patent protection in the next decade, meaning there will be several biosimilars in development looking for a plan. Understanding how to support and develop such a plan matters strategically because this approach:
- Reduces biosimilar development costs by 30 to 50%
- Shortens timelines by 2 to 4 years
- Marks biosimilars as analytically driven, not clinically driven, products
This is good news for patients, enabling faster access to efficacious, safe, quality medicines that drug payers are keen to support.
How regenold UK Can Help
Whether you are new to biosimilars or refining an existing programme, our expert team can guide your regulatory pathway, shape your evidence package, and support interactions with agencies worldwide. Let us help you turn regulatory opportunity into portfolio value.
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Simplify Your Biosimilar Strategy
Whether you're new to biosimilars or refining an existing programme, our expert team can guide your regulatory pathway and support agency interactions worldwide.
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