Trastuzumab biosimilar is under clinical development by Qilu Pharmaceutical and currently in Phase III for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase III drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Trastuzumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Trastuzumab biosimilar overview

Trastuzumab biosimilar is under development for the treatment of metastatic breast cancer. It is administered by intravenous route. The drug candidate is a recombinant humanized monoclonal antibody against HER-2.

Qilu Pharmaceutical overview

Qilu Pharmaceutical (Qilu) develops, manufactures and markets generic drugs and active pharmaceutical ingredients (API’s). It offers products for various therapies such as oncology, cerebrovascular and cardiovascular diseases, infectious diseases, psychological and neurological diseases, respiratory system and eye diseases. The company’s generic drugs include lyophilized powder for injection, powder for injection, small volume parenteral solution, tablets, capsules, granules, ophthalmic solutions, creams, ointments, inhalers and spray; and synthesized, lyophilized, sterile crystallized and fermented APIs. Qilu operates manufacturing facilities with various certifications of US FDA, European Medicines Agency (EMA), PMDA of Japan, Medicines and Healthcare products Regulatory Agency (MHRA) of UK, Therapeutic Goods Administration (TGA) of Australia and other national regulatory authorities. The company markets products across North and South America, Europe, Asia Pacific, and the Middle East and Africa. Qilu is headquartered in Jinan, Shandong, China.

For a complete picture of Trastuzumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 January 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.