Biosimilars are practically the same as an approved biologic drugs that are produced by live organisms and do not differ significantly in safety or effectiveness. Such drug certifications as a clearance from the Food and Drug Administration (FDA) permit them to enter the market, thus expanding patient access to treatments, extending the drug range, and potentially decreasing healthcare costs, which is why these drugs are revolutionary in today’s medicine.
Key Growth Drivers and Opportunities
Increasing Demand for Biologics: The need for biologics that has gone up significantly because they have been very effective in their treatment of chronic diseases and complex diseases has led to the need for more affordable alternatives being desirable, such as biosimilars, to open up the market for growth by creating possibilities for increased production, wider patient access, and less expensive treatment options.
Challenges
The market for biosimilars is limited by various factors such as high expenses for development and production, complicated rules and regulations, difficulties in patents and litigations, low levels of doctors’ and patients’ awareness, as well as worries about the ability of the drug to be easily changed and the safety of the immune system, all of which can hinder the rate of acceptance and market growth.
Innovation and Expansion
Kashiv BioSciences and JAMP Pharma Corporation announce the launch of PEXEGRA and FILRA biosimilars in Canada
In September 20205, Kashiv BioSciences, LLC has announced the commercial introduction of PEXEGRA, a biosimilar matching Neulasta, and FILRA, a biosimilar referring Neupogen, in Canada. Both biosimilars will be commercialized in Canada under an exclusive deal with JAMP Pharma Corporation.
PEXEGRA (6 mg/0.6 mL pre-filled syringe) and FILRA (300 mcg/0.5 mL and 480 mcg/0.8 mL pre-filled syringe) are used to treat neutropenia, which is characterized by a lack of neutrophils, a kind of white blood cell that fights infection and is prevalent in chemotherapy patients. According to IQVIA1, Filgrastim and Pegfilgrastim sales in Canada totaled approximately 57 million USD and 87 million USD, respectively, for MAT June 2025. Filgrastim and Pegfilgrastim have global sales of approximately 1.2 billion USD and 3.1 billion USD, respectively, as of MAT June 2025.
Alkem Introduces Pertuzumab Biosimilar for Breast Cancer in India
In September 2025, Alkem Laboratories has introduced a biosimilar medicine in India for the treatment of breast cancer. The company has launched Pertuza injectable 420mg/14mL, a pertuzumab biosimilar, for the treatment of HER2-positive breast cancer.
Alkem’s Pertuza is a low-cost, indigenously designed and manufactured biosimilar to pertuzumab. Pertuza’s introduction demonstrates this dedication and strengthens our cancer offering.
Inventive Sparks, Expanding Markets
The key players operating the biosimilar market include Siemens, General Electric, Tesla, Sunverge Energy, Inc., ABB, Next Kraftwerke, AGL Energy, Open Access Technology International, Inc., Flexitricity Limited, Limejump Limited, Toshiba Energy Systems & Solutions, Hitachi, Ltd., Olivene, Inc., AutoGrid Systems, Inc, and Centrica.
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