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Biosimilars at STADA – Heritage & Innovation

At STADA, caring for people’s health is at the center of everything we do. In recognition of the continuing need for greater access to life-altering biologic therapies, STADA Specialty is proud to offer a rapidly expanding portfolio of high-quality biosimilar medicines.

Our biosimilars can enable improved access to treatment for patients across a broad range of indications.

Biosimilars have been trusted medicines in Europe for nearly 20 years, since the first European biosimilar approval in 20061. Since then biosimilars have provided nearly 4.5 billion patient treatment days to European patients. STADA was among the pioneers in Europe’s biosimilars sector, having launched Epoetin zeta in 2008. We now have several biosimilars in the portfolio and more in our pipeline.

What are biosimilars?

A biosimilar is a biologic that is highly similar to another biologic medicine:1

Large molecule with a complex structure

Large molecule with a complex structure

Produced from living cells

Produced from living cells

Strictly regulated biomanufacturing and quality control

Strictly regulated biomanufacturing and quality control

Biosimilars are approved according to the same strict standards of quality, safety and efficacy as other medicines:1

Undergo clinical studies

Undergo clinical studies

Undergo clinical studies

Manufactured in licensed facilities

Manufactured in licensed facilities

Strictly regulated biomanufacturing and quality control

Approved by EMA using the same regulatory pathway as the reference product

Biosimilar Development

A comprehensive development program is required to bring a new biologic to the market.2 Biosimilar development is comparative and progresses in a step-wise manner. After extensive analytical and non-clinical studies, comparative and clinical study is conducted to determine comparable quality, safety and efficacy of the biosimilar and reference medicine.

Through this program a biosimilar can rely on clinical trial results achieved by the reference product and avoid unnecessary repetition.1 This can speed up the development process by 1–3 years and reduce development costs by $500–700 million, which can result in the end product becoming more affordable for patients in need.

 

 

 

 

 

Developers of biosimilars are required to demonstrate through comprehensive comparability studies with the reference biological medicine that:

  • their biosimilar is highly similar to the reference medicine, not with standing natural variability inherent to all biological medicines;
  • there are no clinically meaningful differences between the biosimilar and the reference medicine in terms of quality, safety and efficacy or in terms of immunogenicity.

Small differences between highly similar biosimilars and their reference products do not affect critical quality attributes.

 

 

Comparability to reference product

A well-controlled manufacturing process ensures that a biosimilar is highly similar to the reference product. As with an innovative pharmaceutical product, the development process for a biosimilar must focus on key qualities and important attributes that can have clinically relevant implications.

A set of attributes, known as critical quality attributes, can have a direct impact upon the quality, safety and efficacy of a biosimilar.3

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) nationally have emphasized that biosimilars approved in the EU are interchangeable4 from a scientific viewpoint, meaning that a biosimilar can be used instead of its reference medicine, or vice versa, and in place of another biosimilar to the same reference medicine.

Naming: a biosimilar and its reference product have the same active ingredient, thus they have the same International Nonproprietary Name (INN) in Europe. The brand name, however, will be different.

Large molecule with a complex structure

Structure

Pharmacodynamics and function

Pharmacodynamics and function

Safety and efficacy

Safety and efficacy

Extrapolation

Extrapolation of indications for a biosimilar is based on the reference medicine profile.1

The biosimilar matches the reference molecule as demonstrated by the totality of evidence.1,5  Therefore, the biosimilar molecule can be expected to behave the same way as the reference molecule in all indications and patient populations.4

Once biosimilarity has been established, a biosimilar may be approved for additional or all other indications for which the reference product has been approved without the need for additional clinical trials.1,4

This process is not unique to biosimilars. It has been used for many years in reference products that have undergone a manufacturing change.






Substitution & Interchangeability

On 19 September 2022, the EMA and HMA issued a press release and a joint statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. Biosimilars approved in the EU and their reference medicines can be used interchangeably or one biosimilar can be replaced with another biosimilar of the same reference product.4

 

Quality

Quality

Safety

Safety

Efficacy

Efficacy

What benefits can biosimilars bring?

Biosimilars patients

For Patients

  • Improved access to cost-effective biologic treatments
  • Improved access to safe, effective, alternative therapeutic options1,2
Healthcare professional consulting a patient

For Healthcare Professionals

  • Wider choice of treatment options
  • Improved access to safe, effective, alternative therapeutic options1,2
Payers

For Payers

  • Significant cost savings and efficiencies for healthcare systems2
  • Expanded access to biologics and to new medicines through reallocation of resources6

According to the European Medicines Agency, which assesses and regulates biological medicines in the EU, “biosimilar competition should improve patient access to safe and effective biological medicines with proven quality.”7

A white paper from respected market research institute IQVIA shows that biosimilar competition in Europe for 18 biologic molecules has generated cumulative savings at list prices of more than €30 billion8. Biosimilars have provided nearly 4.5 billion patient treatment days to European patients, including around 850 million patient days 2022 alone.

Through the improved value provided by biosimilars competition more patients can be treated with biologic medicines at the same, or even reduced, costs. This was confirmed by a recent analysis of biosimilar competition in European TNF-alpha inhibitor markets, which found that the market entry of biosimilar competition increased the utilization of infliximab, etanercept, and adalimumab on average by 88.9%, 14.6%, and 22.4% respectively.9

For example, real-world evidence from Poland demonstrated the potential for expanding patient access to TNF-alpha inhibitors such as adalimumab, infliximab and etanercept due to cost savings generated through biosimilar competition. This analysis calculated estimated total savings amount to over €243 million for TNF-alpha inhibitors, with overall decrease in the mean annual cost of treatment ranging between 75% and 89%. If all budget savings were spent on reimbursement of additional TNF-alpha inhibitors, a hypothetical total of almost 45,000 patients with rheumatic musculoskeletal diseases could have been treated in 2021.10






Resources

1 European Medicines Agency (EMA). Biosimilars in the EU. Information guide for healthcare professionals. 2019. Available at: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Last accessed March 2023.

2 Biosimilar Medicines Group. Biosimilar Medicines Handbook. 3rd edition 2016. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2016/04/BIOSIMILAR-MEDICINES-HANDBOOK_INT_web_links2.pdf. Last accessed March 2023.

3 Vulto AG and Jaquez OA. Rheumatology (Oxford). 2017; 56 (suppl_4): iv14-iv29.

4 European Medicines Agency (EMA and European Commission): Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU; April 2023. Available at: https://www.ema.europa.eu/en/documents/public-statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf

5 Hobbs AL, Crawford JP. Pharm Pract (Granada). 2019;17(3):1659.

6 Cegfila® SmPC (Feb. 2023).

7 Biosimilar medicines: Overview | European Medicines Agency (europa.eu).

8 https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2022.

9 Frontiers | Biosimilar competition in European markets of TNF-alpha inhibitors: a comparative analysis of pricing, market share and utilization trends (frontiersin.org).

10 Budget impact analysis and treatment availability with biosimilar TNF inhibitors in rheumatic diseases in Poland: real-world evidence using a nationwide database | Annals of the Rheumatic Diseases (bmj.com).