Combination Product Licensing Strategy
This mid- to large-size global generic pharmaceutical organization wanted to introduce a new generic therapeutic drug plus delivery device combined product – a market first – initially into the EU. ELC Group navigated the complex challenge of devising a combined licensing strategy that would fast track entry to European country markets.
Licensing a drug-device combination product is a challenging process – even more so when the combined product is designed for pediatric use. Alongside demonstrating the stability of the formulation, both pre- and post-device loading, the divergence of guidelines and opinions in relation to the SPC requirements for pediatric subsets among key European agencies represented a significant barrier to achieving fast market entry. Indeed, other organizations had tried – and failed – in their attempts to introduce generics, particularly in this therapeutic area.
Representing a key product in its 10-year portfolio, successfully bringing this new combination drug product to market in Europe would mark a critical step for this organization in extending into wider global markets.
With no access to the innovator’s data, the company needed to find an effective way to formulate the combined drug and device product, address the multi-agency pediatric indication approval challenge, and create a PIL format that encompassed a variety of dosages in a manner that satisfied the safety requirements of authorities. Moreover, divergent agency opinions and interpretation of the step-by-step from Quality to Clinical guideline posed a greater challenge.
ELC Group solution
ELC Group’s team of experts set about creating a strategy that would telescope submission timeframes and maximize outcomes, undertaking careful in vitro and PK planning to avoid the necessity for an extended full Phase III study. With this in mind, ELC Group prepared a staggered registration and regulatory intelligence program, kicking off with a pivotal scientific advisory meeting with a lead regulator.
Before preparing a strategy, the ELC Group team undertook a detailed analysis of innovator licensing trends and indication approvals, the findings of which would inform the best approach to take. It then initiated a pre-submission scientific advisory meeting with a targeted lead authority, pre-selecting a regulatory agency with previous experience of authorizing drug and device combination products. With extensive expertise in both drug and device regulatory matters, ELC Group was able to prepare a detailed pre-submission for this crucial meeting, identifying key areas to explore in relation to the registration of such a highly complex product.
Following the advice and guidance obtained as a result of the initial scientific advisory meeting, ELC Group was able to prepare a comprehensive submission strategy. To maximize market penetration, ELC Group then initiated detailed discussions with experts from licensing authorities in each primary target market to define local requirements. It also prepared the post-licensing go-to-market strategy for each country, selecting a primary Marketing Authorization Holder (MAH) and local distribution partners to support local country submissions.
The ELC Group solution comprised:
- Scientific advice and innovator licensing trend and indication approval analysis
- Detailed analysis of key opinions which informed the Submission Strategy
- Selection of Applicants and the MAH
- Finalization of local requirements
- Selection of data to be included in the Marketing Authorization Application (MAA) submission management
- Extensive engagement with the relevant European Competent Authorities (CAs)
- Thanks to the work of ELC Group local experts, licensing for this complex generic combined product was achieved on the first submission and within an impressive 12 month timeframe. There was no requirement for an extended Phase III study, which significantly reduced the go-to-market cost for the client.
- The complex SPC requirements were met by evolving a grouped SPC to cover off all dosages.
- To support entry to local markets, MAH applicants were selected to undertake EU and national pharmaceutical legislation compliance requirements.
- To date, the product has been successfully registered in 16 European countries, with further submissions currently underway in the region.
- The successful closure in many key territories has provided a strong base for entry into new international markets.
- ELC Group has utilized a portfolio of positive opinions from other successful submissions to influence undecided assessments.