The future of biologics.

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The potential benefit of biosimilars

Biologic medicines offer important treatment options for disabling and life-threatening diseases. Approved biosimilars are drugs that have been deemed to be highly similar in quality, safety and effectiveness to an existing, branded biologic. By introducing competition into the biologic market where there are few low-cost alternatives, biosimilars can contribute to increased, more affordable options for patients.1

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Increased patient access

The introduction of biosimilars has resulted in the increased use of biologic drugs in the EU by as much as 100%.2

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​Potential cost savings

Stakeholders benefit from price competition, which is encouraged by biosimilars entering the market.


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Fostering innovation

Competition can disrupt the market and push innovators to develop novel products to sustain commercial success.

Biosimilars are expected to provide cost savings of up to $100 billion by 2020.

According to a paper recently published by IMS, the introduction of biosimilars may result in over $50-$100 billion in savings in the EU 5 and the United States alone by 2020.2

Quality biosimilars require precision.

The successful development and manufacturing of a biosimilar that is highly similar to a reference biologic requires discipline, expertise and an intense focus on the science behind structural and functional similarity.

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Careful analysis of the reference product

Biologics are large molecule products that are complex to develop. By using state-of-the-art technology, biologics can be analyzed to comprehend their critical quality attributes, including the molecule’s structure and function.

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Cell line development

Once the critical quality attributes of the reference product are identified, biosimilar candidate DNA found to express these attributes is refined for replication. Clone selection is determined by quality, performance and similarity.

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Achieving biosimilarity

Throughout the bioprocess development phase, a robust suite of orthogonal analytical methods are employed to further characterize properties such as glycosylation, folding and binding versus the reference product. This creates a comprehensive understanding of the of the biosimilar candidate, with the goal of showing that no clinically meaningful differences exist between the proposed biosimilar and the reference product.

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Clinical confirmation

Once biosimilarity is achieved, developers test for safety and immunogenicity through a clinical program. The cinical strategy is confirmed with regulatory agencies prior to execution. If there is any residual uncertainty remaining, additional confirmatory clinical trials may be required.

Committed to high standards.

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Regulatory approval process

Regulatory bodies such as the FDA and EMA have established strict policies regarding the approval of biosimilar products. Sponsors work with regulators throughout the development program to understand requirements for approval. Evaluation of proposed biosimilars is based on the totality of evidence demonstrated in each application in a multi-tiered approach.

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Scale-up and final product manufacturing

Establishing a secure and consistent supply of biologic drug substance and drug product requires experience, expertise and a commitment to quality. Manufacturers must be compliant with cGMP standards and pass site inspections by regulatory agencies.

See what we’re working on.

Adello is committed to leveraging high science to efficiently manufacture high-quality biosimilars. Our discipline, expertise and focus drives us to select biosimilar candidates that can positively impact health care systems globally. See what products are currently in the works.

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