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European Biopharmaceutical Review
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The first documented administration of insulin as an intervention
in diabetes was in 1922. A relatively crude extract from bovine pancreas
was injected into a 14-year-old boy in Toronto, and, although the first
injection was not entirely without complications, this intervention
ultimately saved his life. The subsequent impact of this discovery on
the lives of countless patients and our industry has been, to say the
least, transformational. Fast forward a century to 2022, and the
biosimilars of biopharmaceutically manufactured, synthetic insulins will
likely be mainstay therapies for diabetes, as Syneos Health's Rafal
Kokolus, Dr Doug Niven, and Rohit Sood discuss how the illness joins the
list of conditions for which all stakeholders are transitioning towards
biosimilar adoption.
If the rapidly expanding and often complex biosimilars universe is
not quite fully in focus for you yet, then articles in the summer 2018
edition of EBR will provide excellent overviews of the state-of-
the-art in defining by sequence (Dr Richard Easton and Dr Andrew Reason
at BioPharmaSpec) and protecting via optimal patent and commercial
strategies for these high-value ‘affordable’ biological therapeutics,
distinct in sequence and synthesis, yet ‘highly similar’ in efficacy and
safety to first generation proprietary forms of which they are
effectively ‘functional generics’ (Boult Wade Tennant’s Jennifer
O’Farrell, and Finnegans’ Sanya Sukduang and Thomas J Sullivan).
The first ever biosimilar drug product approval (by the EMA in
2006) was for a hormone therapy, omnitrope (somatropin), although the
first biosimilar insulin hormone was only approved as recently as 2014.
Antibody biosimilars, ‘adopted’ by the EMA and FDA more recently, have
made much more ‘noise’, arguably because of the premium priced
proprietary market pioneers they can replace. Three articles in this
edition of EBR focus on antibodies as the targeting component of
antibody-drug conjugates (ADCs) in cancer therapy (the team from Aptamer
Group, and Dr Neil Butt from IONTAS). ADCs are an increasingly
important drug class in oncology, evidenced by the fact that, according
to Professor Andreas Pahl from Heidelberg Pharma, more than 70 are now
in clinical trials.
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Shipping with Active Packaging Containers: Three Pre-flight Decisions that Impact the Success of High-value Global Shipments
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It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
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Respiratory Drug Delivery (RDD®) Europe 2019
7-10 May 2019, Estoril Congress Center, Lisbon
Respiratory
Drug Delivery (RDD®) Europe 2019 connects emerging and high-level scientists, academics,
industrial and regulatory specialists, and clinicians. It is a must-attend conference
for companies involved in research, development, testing or marketing of
medicines, devices and services associated with pulmonary or nasal pharmaceutical
products. This year, RDD Europe 2019 will be held in Estoril (Lisbon),
Portugal, May 7-10, 2019, and, as in previous years is jointly organized by RDD
Online and Aptar Pharma.
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