The Decision on Timing in the BPCI Act

2019-01-09T13:51:14+00:00By |

This week, the path to market for biosimilar developers cleared up just a bit. The Supreme Court made a final decision in the three-year lawsuit between Amgen and Sandoz that sets a precedent regarding the interpretation of some widely-contested language in the BPCI Act. The language in question referred to the ‘patent [...]

Clinical Endpoint ANDA Program Optimization Introduction

2019-05-25T17:16:44+00:00By |

Clinical Endpoint ANDA Program Optimization This introduction marks the launch of a series of White Papers dealing with the optimization of Clinical Endpoint ANDA Programs for the generics and specialty pharmaceutical industry. We will be publishing these reports addressing and analyzing different aspects of optimization several times a year and making them [...]

3 Trends in Biosimilars: A 6-Year Outlook

2019-01-09T13:51:14+00:00By |

Over the next five years, the purchase and production of biosimilar drugs can expect to see double-digit growth. As biosimilar drugs become more widely produced, prescribed, used, and accepted, the competitive marketplace will continue to heat up. What are the drivers for biosimilar drug production? And what trends are having an impact on [...]

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The Promise of Biosimilar Drugs

2019-01-09T13:51:14+00:00By |

In 2006, the European Medicines Agency granted its first approval of a biosimilar drug, the human growth hormone, Omnitrope™ (Sandoz), and opened the doors of opportunity for this emerging field of medicine. In 2010, President Obama signed into law the Biosimilars Act, and on March 6, 2015, the FDA formally approved its first biosimilar drug, [...]

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Biorasi Joins GPhA Biosimilars Council to Promote Biosimilar Drug Development

2019-01-09T13:51:14+00:00By |

There is great strength in numbers, and joining forces with some of the world’s most influential companies in the biosimilar industry will position Biorasi to have a more significant impact on biosimilar drug development. To this end, Biorasi is proud to announce that the company is now a member organization of the GPhA [...]

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Making Room for Biosimilars

2019-01-09T13:51:14+00:00By |

Co-authored by Stephanie Finnegan, President Divisional Operations and Dominique James, Editorial Analyst On March 6th, 2015 the FDA announced approval of the first Biosimilar drug in the United States. The similarities between follow-on drugs and follow-on biologics make Specialty Pharmaceutical companies dominant among candidates to successfully usher in this new era of [...]

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Life in the Era of Follow On Biologics

2019-01-09T13:51:14+00:00By |

Co-authored by Dr. Boris Reznik, Chairman and CEO of Biorasi and Dominique James, Research and Editorial Analyst The pharmaceutical industry was changed forever in 1982 when the first biologic was introduced to the market. Novel biologics revolutionized the treatment of many life threatening and debilitating diseases. Now, over 30 years later, it is time [...]

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