Spectrum Pharmaceuticals, Inc. to Make Biosimilar of Roche's Rituximab
Published: Jan 05, 2011
“We are excited at the opportunity to develop our own proprietary biosimilar formulation of rituximab in anticipation of patent expirations for rituximab over the coming years”
“We are excited at the opportunity to develop our own proprietary biosimilar formulation of rituximab in anticipation of patent expirations for rituximab over the coming years,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc.
Biosimilars, or follow-on biologics, are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity and micro-heterogeneity. Biologics are also very sensitive to manufacturing process changes, including the choice of the cell type, production process, purification process and formulation of the biologic into a drug. In view of the complexity and sensitivity of the biologics to manufacturing process, no two biotech medicines can be exactly the same, hence the term “biosimilar.” A number of biosimilar products are already in the market in Europe. Following enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), an abbreviated approval pathway for biosimilars has been created in United States.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future financial results, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, the safety and efficacy of ZEVALIN, FUSILEV, apaziquone, and belinostat, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®, and FUSILEV® are registered trademark of Spectrum Pharmaceuticals, Inc., and TURNING INSIGHTS INTO HOPE™, BELINOSTAT™ and the Spectrum Pharmaceutical logos are trademarks owned by or licensed to Spectrum Pharmaceuticals, Inc.
Rituxan® (rituximab) is a registered trademark of Genentech/Roche.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved. Contacts
Spectrum Pharmaceuticals Paul Arndt Senior Manager, Investor Relations 949-788-6700 x216