Introduction

Cancer is second leading cause of deaths globally which took close to 9.6 Mn lives in 2018. Almost 46% of people died due to cancer were 70 years or older, whereas over 70% of the people died in low-middle income countries. The developed regions such as North America and Western Europe have very good resources to fight with this disease. Whereas many other countries don’t have enough resources to fully fight the disease due to its huge treatment cost and other factors. The two factors mentioned above such as high fatality rate in older people as well as in low-middle income countries show a very worrying trend. The financial strain of treatment both on government budgets as well as on people is a very big factor behind emergence and more R&D in Biosimilars. Globally the market is expected to increase by 10-12% y-o-y till 2025.

Drivers

• High Burden on Healthcare System
• High Fatality Rate in older people (above 70 years of age)
• High Fatality Rate in low-middle income countries
• More Oncology Biologics getting off-patent

Biosimilars in Oncology

Rituximab: EU have already approved first Biosimilar of Rituximab. Truxima by Celltrion Healthcare is licensed for the treatment of chronic lymphocytic lymphoma (CLL), non-Hodgkin’s follicular lymphoma, and diffuse large B-cell lymphoma – for which MabThera is widely used. In US it was launched in Nov 2019 at 10% less price than reference medicine.

Trastuzumab: Ontruzant, produced by Samsung Bioepis, became the first biosimilar to Traztuzumab to get approval in EU. It can be used as a monotherapy or in combination with chemotherapy or hormone therapy for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Next line of Biosimilars approved in EU includes Herzuma (Celltrion Healthcare Hungary Kft.), Kanjinti (Amgen Europe), Trazimera (Pfizer Europe) and Ogivri (Mylan S.A.S.).

 Similarly biosimilars for other reference products such as Bevacizumab, Filgrastim and pegfilgrastrim, Epoetins, etc. are also active in EU & US, as well as the companies are investing in more R&D to bring more biosimilars in the markets.

Companies’ Insights

Biocon: Biocon, in collaboration with Mylan, got US FDA acceptance for one of this recent Biosimilars to Avastin. The drug, which is used to treat patients of lung, cervical, and colorectal cancer, is already available in many developing markets.

Pfizer: In 2019, Pfizer for US FDA approval for its Biosimilar, ZIRABEV™ (bevacizumab-bvzr), to Avastin. The biosimilar is useful for treatment in 5 types of cancers. In EU it received approval for its Biosimilar, RUXIENCE™, a monoclonal antibody, to Rituximab.

Major Players

Competitive Profiles and Future Pipeline Analysis for companies such as Biocon, Mylan, Sandoz, Pfizer, Samsung Bioepis, Teva, Celltrion, Coherus Biosciences, Amgen Inc., Hospira Inc., Ratiopharm GmbH, Apotex Europe Bv, etc.

Major Segmentation

By Product Type

• Monoclonal Antibody
• Immunomodulators
• G-CSF
• Hematopoietic Agents
• Others

By Cancer Type

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Prostate Cancer
• Skin Cancer (non-melanoma)
• Stomach Cancer

By Distribution Channel

• Hospital Pharmacies
• Online Pharmacies
• Retail Pharmacies
• Others

By Geography

• North America
  • US
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Spain
  • Italy
  • Others
• LATAM
  • Mexico
  • Brazil
  • Others
• APAC
  • Australia
  • Korea
  • China
  • Japan
  • India
  • Others
• Africa & ME
  • Israel
  • Turkey
  • Africa
  • Egypt
  • Arabia
  • Others

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