Biosimilars Development – An Ever Changing Landscape

The biosimilars environment is fast-moving and rapidly evolving. The pace of change requires designing clinical programs in line with the latest requirements in targeted markets. It means adapting to operational challenges in a difficult patient recruitment environment and from competition with other biosimilars, as well as novel drugs. Partnering with an experienced, multidisciplinary biosimilars group to navigate the challenges is critical to regulatory and commercial success.

Our Biosimilar Consortium, a team of seasoned experts across many disciplines, is here to help you navigate the regulatory challenges and select the best countries and sites for on-time patient recruitment, crafted in the best commercial strategy for optimal market access and commercialization across the globe.

We have completed almost 50 clinical biosimilar studies with over 50% being global clinical comparability studies in patients and have over 20 PK studies in healthy volunteers.

Our Biosimilar Consortium

We take a holistic view of biosimilar drug development and commercialization, leveraging the expertise of our Biosimilar Consortium. Established in 2011, the Consortium is a cross-functional team of biosimilars experts, including therapeutic physician specialists, biosimilar operational experts, regulatory consultants, biosimilar CMC experts, pre-clinical scientists and commercial consultants, who can partner with you to develop the optimal clinical development and commercial strategy to maximize the value of your asset.

Capabilities Include:

  • Generating Clinical Development Plans

Many originator biologics are approved for a variety of indications and sometimes with different dosing regimens. This provides a wealth of options for comparative clinical studies for the assessment of clinically meaningful differences between the originator and the proposed biosimilar. Leveraging our therapeutic expertise and biostatistical modelling capabilities, we work with the sponsor to design a program including essential PK/PD assessment and clinical comparability with a selection of the most sensitive indications and endpoints based on the latest guidelines by the agencies of the targeted markets. We generate the overall timeline with key medical and operational considerations balancing risk, time and cost.

  • Regulatory Consulting

The biosimilars market is evolving rapidly, with an ever-changing regulatory landscape in both emerging and developed markets. Based on the clinical development plan, our regulatory consulting experts support you in the preparation of the dossier for meetings with the major regulatory authorities:  U.S. FDA (i.e., BPD Type 2), EMA (Scientific Advice meetings) or other agencies such as PMDA, NMPA, etc.

We actively participate in the meetings and help you adjust your program depending on the consolidated feedback from the authorities.

  • Bioanalytical Services

Our scientists’ significant experience in the development and validation of immunoassays for large molecules and biomarkers gives us special insight into biosimilar product development. Work performed in our GLP-compliant ligand binding group includes proprietary and non-proprietary pharmacokinetic and immunogenicity assays, as well as a wide range of cell-based and enzymatic assays. We understand what is necessary to support biosimilar assay development and validation from pre-clinical through clinical analyses. Our ever-expanding menu of standard and custom assays are optimized for the quantitation of multiple serum analytes.

Our immunoassay capabilities include single analytes and multiplexing using ELISA, ECLA and radioimmunoassay. In addition, we have a fully-equipped cell-based assay lab.

  • Phase I Pharmacokinetic Studies in Healthy Volunteers

Our unique model enables rapid set up of PK/PD studies in healthy volunteers through our infrastructure in the U.S., Canada, Europe and Australia. We have the bed capacity to accommodate even the largest PK studies for monoclonal antibody biosimilars. 

Within the volunteer database, there is a large number of subjects of Japanese origin which enables us to conduct bridging studies to gain PMDA approval in Japan.

  • Cost Efficient and Lean Phase III Clinical Comparability Studies

Except for smaller protein drugs, most biosimilar development programs require one or more comparative clinical studies in patients. Depending on the molecule, these studies typically require from 300 to more than 700 patients and are global in scope.

Patient recruitment is best executed there is limited availability of the originator drugs, putting the focus on emerging markets for these studies. We have the geographic reach and the local knowledge to expedite your clinical trial submission.

We provide access to qualified investigators with the required training, expertise and patient recruitment potential for our customers' needs. Our protocols are designed to minimize the burden on physicians and patients, driving high acceptance and delivering strong enrollment.

  • Market Access Strategies and Real World Evidence

We understand the commercial complexity that follows regulatory approval and can help you navigate it by mapping out routes to market, understanding healthcare/payer mechanisms that influence access, engaging the multiple stakeholder groups who might influence adoption and, ultimately, outlining how originators and competitors can compete to attain market share.

  • Drug Development Experience With Biologics

We’ve helped develop biosimilars across a range of molecules, including simple protein drugs, enzymes and monoclonal antibodies, and indications such as autoimmune diseases, cancer, ophthalmology and endocrine disorders. Our depth of expertise and strength of experience globally, across the many functions necessary for successful biosimilar development, regulatory approval and commercialization, make us your CRO and CCO of choice.