Biosimilars are medicines made to be highly similar to an already approved biological drug produced from living cells, with no meaningful differences in safety or effectiveness. They matter to investors because they introduce lower‑cost competition to expensive biologic treatments—similar to how generic drugs compete with brand drugs—but involve more complex manufacturing, regulatory review and patent risk, which can affect market share, pricing and profit margins across the sector.
loss of exclusivityregulatory
Loss of exclusivity is when a product’s protected period — such as patent protection or regulatory exclusivity — ends and competitors are legally allowed to sell equivalent versions. For investors, this often means the original seller can face sharp drops in sales and profit margins as lower-priced competitors enter the market, similar to a local shop losing its sole supplier and suddenly competing with many discount stores.
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The proposed combination will create a differentiated global biosimilars platform that leverages Kashiv BioSciences’ development and manufacturing capabilities with Amneal Pharmaceuticals’ commercial strengths
Complementary acquisition will accelerate biosimilar pipeline and strengthen U.S. commercial position for affordable medicines
PISCATAWAY, N.J.--(BUSINESS WIRE)--
Kashiv BioSciences, LLC (“Kashiv”), today announced that it has entered into a definitive agreement to be acquired by Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal”). The transaction is subject to approval by Amneal shareholders, receipt of regulatory approvals and satisfaction of customary closing conditions and is expected to close in the second half of 2026.
This acquisition combines Kashiv’s extensive expertise in the development and manufacturing of biosimilars with Amneal’s scale and commercialization capabilities. Kashiv is headquartered in Piscataway, New Jersey with operations in the U.S. and India. Amneal is headquartered in Bridgewater, New Jersey, and is a leading biopharmaceutical company with one of the largest affordable medicine businesses in the U.S.
Together, the companies will establish a fully integrated biosimilar platform at scale, to deliver high-quality, affordable therapies, expand patient access, and strengthen their position in the global biopharmaceutical landscape.
“We are thrilled to combine Kashiv’s highly complementary portfolio and capabilities with Amneal at this critical inflection point for the biosimilar market, particularly in the U.S.,” saidDr. Sandeep Athalye, Chief Executive Officer at Kashiv. “Our companies share a deep-rooted commitment to high-quality, complex medicines, and this transaction builds on the meaningful work we have accomplished through our partnership of more than ten years. We look forward to building on our proven track record of product approvals and advancing our biosimilars pipeline as we work together to expand patient access to life-changing therapies.”
“As biosimilar adoption accelerates and the industry enters an unprecedented period of biologic loss of exclusivity, we see a compelling opportunity to establish leadership and scale in a rapidly expanding market,” said Chirag Patel, Co-Founder and Co-Chief Executive Officer of Amneal. “With Kashiv, Amneal becomes a fully integrated global biosimilars leader at the forefront of the next wave of U.S. affordable medicines. This acquisition is a natural next step in our strategy to build a leading, diversified biopharmaceutical company, and we are confident it will drive accelerated growth and long-term value creation.”
“This acquisition establishes Amneal as a fully integrated global biosimilar platform at scale,” said Chintu Patel, Co-Founder and Co-Chief Executive Officer of Amneal. “By combining Kashiv’s deep R&D and manufacturing capabilities with our commercial strength, we are creating a differentiated platform well-positioned to deliver a strong and consistent cadence of biosimilar launches going forward. Together, we will expand access to high-quality, affordable biologic medicines for patients while driving long-term growth.”
J.P. Morgan is serving as Kashiv’s financial advisor for the transaction, Holland & Knight LLP is serving as legal counsel, and Dhinal Shah Associates is serving as India legal counsel.
About Kashiv BioSciences
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the U.S., together with its subsidiaries in India (collectively, “Kashiv BioSciences”) operates with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. For additional information, please visit kashivbiosciences.com and follow us on LinkedIn.
About Amneal
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Amneal was founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel and built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex generic, specialty and biosimilar medicines, delivering more than 160 million prescriptions annually, primarily in the United States. Our Affordable Medicines segment spans retail generics, injectables, and biosimilars. Our Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Our AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers. For additional information, please visit amneal.com and follow us on LinkedIn.