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Deal news: Bio-Thera Solutions and Intract Pharma

Bio-Thera Solutions and Intract Pharma announced at the end of last month that they had entered into a global collaboration and licensing agreement that gives Bio-Thera access to two oral delivery technologies for monoclonal antibodies to develop treatments for chronic gastrointestinal inflammatory diseases.  According to Intract’s press release, “Intract has…

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The FDA’s Purple Book

As we previously reported, the “Consolidated Appropriations Act” enacted in December of last year contained a provision that required FDA to create a searchable, electronic database of biologics and to update it with patent information provided to an applicant during the patent dance.  As of the effective date of June…

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Celltrion Shares Recent Biosimilar Development News

Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA).  According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients…

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House Introduces Bill, BIOSIM Act, Designed To Lower Drug Costs

On April 23, 2021, Congressmen Schrader and Kinzinger introduced H.R. 2815, the Bolstering Innovative Option to Save Immediately on Medicines Act (“BIOSIM Act”).  The bill provides for temporary increased reimbursement to hospitals and doctors for biosimilar drugs from the average sales price (ASP) of the drug plus 6% to the…

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Women’s History Month: Janet Woodcock

In honor of Women’s History Month, Big Molecule Watch will highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Janet Woodcock, current acting Commissioner of the U.S. Food and Drug Administration (FDA) and director for Drug Evaluation and Research, who has held a number…

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