Sameera Tak

Facing Biosimilar Competition:

Value & Access Readiness Strategies

Sameera Tak


Loss of exclusivity is notorious for giving pharma and biotech executives sleepless nights particularly in highly competitive biosimilars space, if you have been an innovative, originator company for years  and have not been exposed to the complex and fast paced procurement environment Biosimilars environment, arrival of a biosimilar can be commonly viewed as a rapid price erosion apocalypse meaning value of your originator brand will go downhill right at the entry of the first competitor and there is not much one can do, however I differ in my opinion.

Recent EU regulation1 on interchangeability on Biosimilars v/s will have a fundamental shift on the pace of Biosimilars adoption in its member states. As EU joint statement clearly points out interchangeable use of biosimilars is already practiced in many Member States, and this joint position harmonises the EU approach. It brings more clarity for healthcare professionals and thus helps patients to have increased access to biological medicines across the EU.

Originator companies facing LOE in the near/midterm are thinking what does this means for its innovative brand/s which is going to lose exclusivity and face biosimilar competition, however the most frequently asked question is how best can they prepare to defend their brand at the arrival of a biosimilar and maintain market share.

Based on Medicines for Europe infographic published in 2020, data suggests that upon entry of Biosimilars in a market dominated by an originator, market volume expands, according to the infographic entry of Biosimilar Filgrastim  increased patient access by 44% 2  

Medicines for Europe is also advocating for sustainable procurement practices in Biosimilars procurement to ensure level playing field within the competitors benefits of which eventually go to the patient community and have endorsed few examples in countries with sustainable procurement practices in their reports.3

The Impact of Biosimilar Competition in Europe in 2021 report4  states that despite year 2020 being impacted by the COVID-19 pandemic, the volume of biosimilar prescribing has generated a record high in savings from biosimilar competition. The list price savings (excluding confidential rebates and discounts) accounted for €5.7 billion.

No one can argue but nod and agree that this is great for patients and the healthcare systems however an underlying take-away is that there is and will be market share for all competitors even more so when sustainable procurement practices become prevalent.

In a typical biotech set up Value and Access Teams, are usually focussed on first launch readiness, HTA re-assessments and renegotiations, which is much needed for near-term and midterm planning and execution, however scenario planning should and must include space for Biosimilar readiness ideally prior 5-6 years to the entry for the first biosimilar competitor.

Question is what the starting point is and how can Value and Access teams pioneer Biosimilar readiness. AESARA experts have outlined 3 strategic starting points which  fundamental for Biosimilar readiness as an originator company for your brand.

  1. Identifying your value differentiators v/s Biosimilar competition
  2. Driving Internal readiness prior to the market entry of the 1st biosimilar
  3. Mapping and shaping of tender and contracting markets to prepare procurement bodies to make value based decisions on tenders

1. Identifying your value differentiators v/s Biosimilar competition

What is it that is differentiating your brand v/s the Biosimilars, is it Patient experience, Physician experience, will you have data to substantiate those differentiators?

What is your data differentiation strategy, have you aligned on it cross functionally through integrated evidence planning approach?

Will you have RWE data available to demonstrate differentiation of your brand v/s competitors in your tender dossier submissions?

It is key to identify those value differentiators and lay down a road-map to generate data to support those value differentiators.

2. Driving Internal readiness prior to the market entry of the 1st biosimilar

Re-think about pricing governance, overtly complex pricing governance will not work considering the fast-paced tendering environment, you will need to re-vamp your pricing policies and governance structure to meet the agility of the market.

What about systems and processes to collaborate with affiliates, have you thought about tender management system to help affiliates manage day to day operations when it comes to tender submissions and monitoring?

Have you thought about supplying tools such as Global Tender dossiers with differentiated  value messages while giving room to the affiliates to tailor those value messages to suit their individual market needs when getting ready for tender submissions?

3. Mapping and shaping of tender and contracting markets:

What is that the tender authorities will be looking for when making decisions on how to award tenders in the future, based on what criteria?

Have you considered ad-boards to get feedback from the procurement bodies to understand what the unmet needs are in the therapeutic area?

Is it securing supply chain, is it improving patient care, is it ensuring that the products which enter the tenders have low carbon footprint?

Start preparing your affiliates to talk to the procurement bodies and understand what will drive differentiation in the tenders, this early dialogue will not only help adapt value and access strategies but also supply chain readiness which can take years , your supply chain colleagues will thank you for early planning.

Have you thought about tender mapping strategies at affiliate levels, tender mapping can as be simple as knowing that there will be 1 National Level tender in Denmark which will be issued annually  v/s 700+ tenders in the Spanish market where tender award criteria which could vary from supply chain continuity, additional patient support services, 24X7 courier helpline, packaging requirements such as 2d matrix on the labels and would have varied durations and calendars.

Preparing as early as 5-6 years in advance before the arrival of the first Biosimilar will give you and your Value and Access teams and cross functional stakeholders sufficient time to lay strong foundations on Biosimilar Readiness strategies and tactical execution.

This early on planning will clearly affect how your brands’ value will be maintained in a competitive market which is rapidly evolving and eventually your preparation will have a broader impact on the patient community who would continue to benefit from the choices of affordable treatments offered in the market including your company’s brand.

Are you facing dilemma on Biosimilar competitor readiness strategies and do not know where to begin, get in touch with one of our experts on Biosimilar competitor readiness strategist [email protected]


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