FDA Law Blog: Biosimilars

MARCH 3, 2025

The American Conference Institutes 3rd Annual Forum on Advanced Therapeutics is scheduled to take place from March 19-20, 2025, at the Seaport Hotel in Boston, MA.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

MAY 23, 2023

This change significantly diminishes the protection afforded by market exclusivity by allowing off-patent competitors to submit marketing authorisation applications for generic or biosimilar products with less than two years of exclusivity remaining. The standard period of orphan market exclusivity is set to be reduced from ten to nine years.

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Pharmaceutical Companies Pharmaceutical Companies Biosimilars Packaging 52

Express Pharma

JULY 10, 2024

With advancements in biotechnology, robust scientific capabilities, cost-effective manufacturing processes, a large workforce and a shift towards more complex biologic drugs, India is at the cusp of a huge opportunity to emerge as a leader in biopharma. On a monthly basis, this market adds around $1.16 billion.”

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Vaccines Drug Development Process Improvement Biosimilars 96

FDA Law Blog: Biosimilars

JULY 9, 2024

Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.

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Drug Development Communication Documentation Labelling 59

Express Pharma

MARCH 6, 2025

Large pharma companies in India have already been appointing North America-focused Regulatory Affairs leadership roles, responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.

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Biosimilars Drug Development 95

Express Pharma

JANUARY 1, 2025

The third manufacturing facility – Unit III in Harohalli is under construction and is expected to be fully operational in the first half of 2025. Anthems business comprises CRDMO services and the manufacture and sale of Specialty Ingredients. Its revenue from operations increased by 34.3 per cent to Rs. 1,056 crores in Fiscal 2023.

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Biosimilars Drug Development 105

FDA Law Blog: Biosimilars

JANUARY 30, 2025

To this end, the December 2024 draft guidance and a companion guidance published January 7, 2025, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (the January 2025 draft guidance ) describe FDAs latest thinking on what it means to conduct a confirmatory trial with due diligence.

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Drug Development Documentation 105

Express Pharma

FEBRUARY 5, 2025

Looming patent expiries Patent expirations have been a significant opportunity for the Indian pharma space that is dominated by generics and biosimilars manufacturing. This looming patent expiration is likely to drive interest in mergers and acquisitions, with 77 per cent of surveyed executives expecting M&A to increase in 2025.

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Biosimilars Vaccines Drug Development 90

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

Documentation 88

Documentation Drug Development 88

PhRMA

MARCH 28, 2025

Patents and other IP protections over the past 25 years have fueled the delivery of over 750 new medicines for debilitating and devastating illnesses, such as cancer, heart disease and many rare diseases, by giving innovators the legal protection and confidence they need to take on the significant costs and risks associated with drug development.

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Drug Development 52

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

On February 5, 2025, a press release caught our eye Arbor Biotechnologies announced that ABO-101, its investigational therapy for the treatment of primary hyperoxaluria type 1 (PH1), received a rare pediatric disease designation.

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Drug Development 59

Safe Biologics

MARCH 10, 2025

Small molecule drugs make up over 90% of prescriptions filled in the U.S. Yet, since the IRAs implementation in 2021, investment in small molecule drug development has dropped by 70% as manufacturers shift resources toward biologics, which have more favorable financial incentives under the law. Read the full statement here.

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Biosimilars Independent Pharmacies Drug Pricing Vaccines 130