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India's economic engine is revving up, but navigating the global headwinds requires sharp strategy. The rupee's recent volatility against the dollar underscores the complexities facing Indian businesses, impacting everything from import-export trade to domestic inflation. This week alone, we've seen significant shifts in the IT sector, with major players announcing restructuring and a renewed focus on AI-driven solutions. Meanwhile, the burgeoning startup ecosystem continues to attract substantial funding, despite a cautious global investor sentiment. The government's recent policy announcements on infrastructure development and digitalization are poised to further shape the business landscape, creating both opportunities and challenges for entrepreneurs and established corporations alike. Understanding these market dynamics is crucial for success in today's rapidly evolving Indian economy. Stay informed with Abtak.com for the latest insights and analysis on key sectors including finance, manufacturing, and technology – empowering your business decisions in a dynamic market. Explore the complete business news section now to stay ahead of the curve.

3
BusinessHealthOct 31, 2025 02:47 PM

USFDA moves to accelerate biosimilar development and lower drug costs

New Delhi [India], October 31 (ANI): The U.S. Food and Drug Administration (FDA) has announced major steps to make it faster and less costly to develop biosimilar medicines, lower-cost "generic" alternatives to biologic drugs used to treat serious and chronic diseases. In a new draft guidance, the FDA has proposed major updates aimed at simplifying biosimilarity studies and reducing unnecessary clinical testing. The agency also launched a separate initiative to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, allowing patients and pharmacists to choose affordable options more easily. It also noted that the expensive biologic drugs account for only 5 per cent of prescriptions in the U.S. but make up 51 per cent of total drug spending as of 2024. Although FDA-approved biosimilars are as safe and effective as branded biologics, their market share remains below 20 per cent. So far, the FDA has approved 76 biosimilars, which is only a small fraction compared to more than 30,000 approved generic drugs. Notably, only about 10 per cent of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development. Health and Human Services Secretary Robert F. Kennedy Jr. said, "Today's announcement of biosimilar reform furthers President Trump's directive to lower drug prices for the American people. This bold action by the FDA accelerates biosimilar development, drives market competition, expands patient options, and advances our mission to Make America Healthy Again." FDA Commissioner Marty Makary, M.D., M.P.H., added that biosimilars could significantly reduce healthcare costs. "By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans," he said. The FDA's new draft guidance, "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies," is based on data and experience since the first biosimilar approval in 2015. Comparative efficacy studies, which take one to three years and cost about USD 24 million on average, have shown low sensitivity compared to other analytical assessments. The updated guidance now allows developers to rely more on analytical testing instead of human clinical studies. Additionally, the FDA will generally no longer recommend "switching studies" that were previously required for interchangeable biosimilars but not for generic drugs. These changes are expected to reduce development time, costs, and confusion among patients. The biosimilar approval pathway was created in 2010 under the Biologics Price Competition and Innovation Act to promote competition in markets dominated by high-cost biologics. (ANI)

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HealthNov 26, 2024 01:29 PM

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BusinessJan 21, 2025 11:24 AM

Gold benefits from softer dollar

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HealthJan 21, 2025 11:14 AM

Apollo partners with University of Leicester to establish center for digital health & precision medicine in India - ET Government

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Canada's PM faces backlash for inviting India's Narendra Modi for G7 summit

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Axiom-4: With hugs and cheers, Shubhanshu Shukla floats in ISS- first visuals | India News - Times of India

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BusinessJun 07, 2025 09:17 AM

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BusinessJun 05, 2025 10:02 PM

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PoliticsBusinessEntertainmentJun 27, 2025 10:52 AM

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BusinessFeb 04, 2025 05:12 PM

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BusinessMay 29, 2025 02:24 PM

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BusinessJun 05, 2025 09:07 PM

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HealthNov 28, 2024 10:52 AM

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HealthDec 02, 2024 12:02 PM

HEJJE, India's First Luxury Transition Care Centre, opens in Bangalore

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BusinessDec 02, 2024 03:44 PM

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OtherJun 02, 2025 02:56 PM

FDA Suspended Zepto's Dharavi Centre After Fungus Growth Discovered In Food Items

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BusinessJun 05, 2025 10:05 PM

Aditya Birla Group acquires Cargill's speciality chemical manufacturing facility in US

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Stampede at RCB event: Bengaluru police chief, key officials suspended

Bengaluru: The Karnataka government on Thursday took strong action against the police officers allegedly responsible for the Bengaluru stampede, suspending several high-ranking officials, including the city's police commissioner. Addressing a press conference, Chief Minister Siddaramaiah also announced a one-man commission to probe the lapses that triggered the deadly stampede. "Cubbon Park Police Station police inspector, station house master, station house officer, ACP, Central Division DCP, cricket stadium in-charge, additional commissioner of police, commissioner of police have been susp ...Read More >

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"India capable of addressing Pakistan's cancer of terrorism": BJP MP Gulam Ali Khatana

New Delhi [India], June 8 (ANI): BJP MP Gulam Ali Khatana, who was part of the all-party parliamentary delegation to Europe, said that during their recently conclued visit they successfully communicated India's development story and its resolute stand against terrorism, particularly emanating from Pakistan. Highlighting the delegation's key discussions during the tour, Khatana told ANI, 'We discussed how we dismantled the terrorism factory in Pakistan by responding... We also talked about tourism infrastructure, G20 Summit, and projects like the six-lane roads, bridges, solar initiatives, our ...Read More >