In the global biosimilars market, the sands are shifting underfoot. It's time for all stakeholders to re-examine the present environment and re-set expectations for the future. From the creation of a regulatory pathway for biosimilars in the EU only three biologics experienced EU biosimilar competition until the launch of Remsima/Inflectra in 2013, and none have (as at Jan 2014) been launched in the U.S. for lack of a biosimilar approval pathway. With uptake on the existing biosimilars very measured, it was a period of relative calm—bordering on stasis—in mature markets.

On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability standard under the Public Health Service Act (PHS Act or the Act). According to the Act, an interchangeable biosimilar may be substituted for the original biological product without the involvement of a prescriber, similar to the way generic drugs are routinely substituted for brand name drugs at the pharmacy level. The Final Guidance, entitled “Considerations in Demonstrating Interchangeability with a Reference Product,” is shorter than the draft version released over two years ago, in response to industry feedback, but generally tracks the original policy positions proposed in the draft, with a few notable exceptions summarized below.

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IMA Change management consultants supporting transformational change apply reinforcement to speed benefit realization for business transformation.

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Institut of Bioinformatics

Interchangeability Interchangeability is defined by statute in the United States to mean that the product may be substituted for the reference product without the intervention of the physician who prescribed the reference product. The legal standard for interchangeability is an additional standard beyond demonstration of biosimilarity. According to guidance issued by the FDA in May 2019, in order for a biological product to be deemed interchangeable, the information submitted must be sufficient to show that: The biological product is biosimilar to the reference product and can be expected to produce the same result as the reference product in any given patient For a biologic product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch Substitutions In the United States, although Federal law gives the FDA authority to license biologic products as interchangeable, it is the state laws that govern the substitution of biologics and pharmaceuticals.

Neurological diseases, particularly in the context of aging, have serious impacts on quality of life and can negatively affect bone health. The brain-bone ax...

Conjugated estrogens is a mixture of estrogens used in estrogen replacement therapy for menopause and hypoestrogenism, used in the treatment of various malignancies, and used in the treatment of postmenopausal osteoporosis.

Mr. Janus was formally the Chief Executive Officer of ES Cell International Pte Ltd and led the ESI BIO Research Products Division at BioTime Inc. before joining Asc..

Learn about the key elements of biosimilar formulary review and what to consider to facilitate organizational adoption of biosimilars.

Lecture Notes in Electrical Engineering Volume 107For further volumes: http://www.springer.com/series/7818 James J...

Jeffrey Janus, the Director, Senior Vice President Operations ISCO; CEO of Lifeline Cell Technolog of International Stem Cell Corp, made $578,258 in total compensation during 2011, according to salary benchmarking data.

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These documents give a detailed overview of a specific topic. Currently this includes: NAVGUIDE; VTS Manual; and CLU Manual. The NAVGUIDE covers all aspects of Aids to Navigation (AtoN) and is updated every four years at each IALA Conference. The VTS Manual covers all aspects of Vessel Traffic Services and is updated every four years at each Symposium.