Medical Writing Generics and biosimilars Insulin biosimilars

Volume 28, Issue 2 - Generics and biosimilars

Insulin biosimilars


Insulin was first purified in 1921 by Frederick Grant Banting and Charles Herbert Best at the University of Toronto. Soon after, the benefits of using insulin to treat diabetes was discovered, the patent was sold to the University of Toronto for $1, and Eli Lilly received the contract to manufacture insulin. Banting believed that insulin must be widely available for treating diabetes. A century later, insulin is so expensive that 50% of the estimated 100 million patients that need it lack reliable access. With many of the patents for insulin expiring and forthcoming changes to the US biosimilar regulations, things should be about to get better for people with diabetes. Biosimilar insulin products are expected to reach the US markets, and it will be interesting to see who achieves success.

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James Visanji Tribute
President’s Message
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own


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My First Medical Writing

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Regulatory Matters

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