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. 課題解決をナビゲートする経験豊富な多分野横断型のバイオ後続品グループとの提携が、薬事上、商業上の成功を収める鍵になります。
サイネオス・ヘルスのバイオ後続品コンソーシアムは、多分野からの経験豊富な専門家で構成されたチームです。規制関連の課題を解決し、適時適格に被験者募集を行うため、最適な国、最適な実施医療機関を選定し、世界中の市場アクセスと製品化を最適に実施するコマーシャル戦略のもと、お客様の試験における規制上の課題を解決するお手伝いをします。
当社は約50のバイオ後続品試験を実施し、そのうちの50%がグローバル比較試験であり、健常被験者に対する試験は20PK以上経験があります。
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.
コンソーシアムは次のようなサービスをご提供します。
- 臨床開発計画の策定
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.
- 薬事規制
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.
弊社コンサルタントが積極的に面談に参加し、規制当局からのフィードバックを総合して、お客様がそれに応じて適切にプログラムを調整できるようにサポートします。
- 生物分析サービス
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.
- 健常被験者を対象としたフェーズI・薬物動態試験
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.
ボランティアデータベースには、多数の日本人被験者が登録されており、日本でPMDAの承認を得るためのブリッジング試験を実施することができます。
- コストパフォーマンスに優れた 第III相・生物学的同等性試験
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.
- 市場アクセス戦略およびリアルワールド・エビデンス
新薬の承認取得後は、商品化に纏わる複雑な問題が待っています。サイネオス・ヘルスでは、市場化ルートのマッピング、アクセスに影響を及ぼす診療／保険のメカニズムの理解、製品の採否に係わる複数のステークホルダーグループへの対処、また最終的に先発品と競合品の市場占有率および競合状況を概説することにより、お客様の取り組みをサポートします。
- 生物製剤における医薬品開発の実績
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.
