Translational Medicine

QPS Full-Service Support for Global Biosimilar Product Development - May, 2013

Biologic medical products, more commonly known as “biologics” are therapeutics derived not from chemical synthesis, but from natural sources such as cells and tissues or processes involving recombinant DNA technology. Once the pipe dream of the pharmaceutical industry, complex biologics now hold a prominent spot among the therapeutic options for the treatment of disease. Old fashioned biologics such as vaccines and blood products have been upgraded and now include molecules such as therapeutic monoclonal antibodies, fusion proteins and oligonucleotides. Over 900 biologics targeting more than 100 diseases are currently in development (1). This class of therapeutics will have a profound effect on how we treat and manage diseases in the fields of rheumatology, neurology, oncology, gastroenterology and cardiology. The costs of developing, producing and prescribing these medications has greatly affected the economics of the pharmaceutical industry as well.

A number of blockbuster biologics will be losing patent protection in the near future.Business Standard reports that twenty-one biologics with a market value of about $54 billion will be losing patent protection by 2019 in the US alone. In 2013, seven drugs with a market value of $19.4 billion will go off patent (2). As with small molecule drugs, patent expiry has created an enormous opportunity for companies brave enough to take on the risk (and the cost) of introducing new therapeutics.

Biosimilars as “large molecule generics”

The term Biosimilar refers to a product with properties highly similar to a currently marketed biological medical product (i.e. reference product). The reference product serves as the standard against which all biosimilar products are evaluated. Specifically, there should be no “clinically meaningful differences” in the safety, purity and potency of the biosimilar compared to the reference product. Because biologics are so complex, a “generic” biological product can only be made to be similar, not identical, to the reference product.

The Patient Protection and Affordable Care Act (Affordable Care Act) of 2010 created an abbreviated approval pathway for biologics that are demonstrated to be “biosimilar to” or “interchangeable with” an FDA-licensed biological product. Biosimilar development programs may rely on existing scientific knowledge about characteristics of the reference product. Thus, a biosimilar may be licensed based on less than a full complement of non-clinical and clinical data.

QPS has extensive experience with biosimilar programs

Since 2007, QPS’ Translational Medicine group has been working to develop and validate methods for all major biosimilars of interest, in support of global biosimilar product development. Our experience includes numerous low molecular weight heparin programs and work on recombinant protein drugs. More recently, QPS has delivered multiple PK, ADA and neutralizing antibody (Nab) detection assays in support of several high profile monoclonal antibody biosimilar programs that include Rituximab, Trastuzumab, Adalimumab, Bevacizumab, and Infliximab.

To date, more than twenty assays have been developed and validated in an effort to make QPS the preferred provider of biosimilars support. In particular, the Translational Medicine group has extensive experience in developing Nab assays, particularly the cell-based functional assay. Four cell-based Nab assays have been developed over the past two years in support of biosimilar programs, with six additional assays developed for other innovative biologics.

QPS Biosimilar Initiative

Based on QPS’ bioanalytical strength and global capability in preclinical, toxicology and clinical research, QPS offers integrated, “full-service” support for global biosimilar product development. We will:

  • Advise on CMC manufacturing, processes, and characterization
  • Review CMC data, manufacturing processes and regulatory advice on CMC regulatory submissions
  • Act as a regulatory liaison; design and prepare product development plans
  • Design and conduct non-clinical PK and toxicology studies
  • Design and conduct clinical study protocols (Phase I and Phase III) for biosimilarity evaluation
  • Perform GLP regulated bioanalysis for preclinical and clinical samples (PK, ADA, Nab, Biomarkers and Dosing Solutions/Drug Potency)
  • Perform PK/PD analysis and toxicology studies
  • Assist with pharmacovigilance
  • Engage in medical monitoring/oversight
  • Review plans and study data, and meet with regulatory agencies (EMA, FDA or local regulatory authorities)
  • Prepare regulatory submissions
For detailed discussion, please contact:

LingSing Chen, Ph.D. 
VP and Global Head of Translational Medicine,
(302) 453-5904,

Stop by the QPS Booth at the upcoming 2013 AAPS NBC Meeting in San Diego, May 20-22, 2013.

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