MHRA updates biosimilar guidance to allow interchangeability between products

Regulatory NewsRegulatory News | 07 November 2022 |  By 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use the same reference medicinal product (RP).
 
On 6 November, the British regulatory agency updated a 2021 document titled Guidance on the licensing of biosimilar products. It has expanded the interchangeability section of the document to account for biosimilars that have the same RP.
 
“Once authorized, a biosimilar product is considered to be interchangeable with their RP, which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect,” according to the guidance. “Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP.
 
“As a result of interchangeability, switching patients from one product to another (RP or biosimilar) has become clinical practice,” the agency added. “The decision rests with the prescriber in consultation with the patient, in line with the principles of shared decision making; both need to be aware of the brand name of the product received.”
 
MHRA also emphasizes that all biological medicines, including biosimilars, should be prescribed by brand name.
 
The guidance broadly outlines the requirements the MHRA has for biosimilar developers looking to market their products in Northern Ireland and the UK. In their guidance, the agency also lists guidelines from the  Committee for Medicinal Products for Human Use (CHMP) that applicants should consider when developing their biosimilar, as well as local laws.
 
While developers can use biosimilars interchangeably if the RP is the same, the RP itself must already be licensed in the UK or in the EU via the centralized, decentralized, or mutual recognition procedures between the EU and the UK.
 
“In order to use non-Great Britain RP in clinical studies, evidence should be provided that the non-Great Britain RP is representative of the Great Britain RP, with suitable information … or analytical bridging data,” wrote MHRA. “In case of doubt, scientific advice is recommended to confirm choice of a suitable RP. Note that all non-Great Britain RP must be authorized in and sourced from a country with similar scientific and regulatory standards (examples would be: EU/EEA, Switzerland, USA, Canada, Australia, Japan).”
 
MHRA states that a biosimilar should be “highly similar” to the physiochemical properties of the RP as well as biological activity/potency and clinical profiles. It also states that any differences between the biosimilar and the RP must be “duly justified” when considering their potential effect on safety and efficacy.
 
“The posology (dose and frequency of dosing) and route of administration of the biosimilar must be the same as those of the RP but deviations from the RP are possible, such as the strength (for example, higher concentration to allow for a smaller injection volume, more suitable for pediatric indications), pharmaceutical form, formulation, excipients or presentation,” wrote MHRA. “These require justification and may need additional data. Patient acceptability should also be considered.”
 
The guidance further elaborates on issues such as what should be included in a marketing application, considerations for clinical and non-clinical trials, product labeling requirements, risk management, and traceability of the product when it gets to market.
 
Guidance
 

 

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