Therapeutic Class

Complex Sandostatin Manufacturing Holding Off Competition, Novartis

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The complexity to manufacture the growth hormone inhibiting peptide Sandostatin will ensure protection from competition, says Novartis. 2017 sales of the acromegaly peptide Sandostatin (octreotide) were down slightly on the previous year, but still brought in US$1.6 billion (€1.3 billion) for Swiss biopharma Novartis. During the firm’s recent first quarter financial call, board member Elizabeth Doherty told stakeholders that while the firm is always looking at potential risks from competition, “we know ourselves with our own experience how difficult it…

April 27, 2018

AbbVie Braces for 20% Erosion as EU Humira Biosimilars Assemble

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AbbVie expects impact from Humira (adalimumab) biosimilars in Europe beginning the fourth quarter but remains confident there will be no direct US competition until 2022. AbbVie is preparing for Humira biosimilar entrants beginning in the fourth quarter 2018, the firm said during a first quarter conference call. A settled lawsuit with Samsung Bioepis earlier in the quarter laid the way for the Korean firm’s adalimumab biosimilar Imraldi to be launched as soon as October 16 by commercialization partner Biogen. Meanwhile,…

April 26, 2018

Another Biosimilar CRL for Pfizer, but Manufacturing not the Cause

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Pfizer has received a US FDA complete response letter (CRL) for its proposed version of Roche’s breast cancer monoclonal antibody Herceptin (trastuzumab). Pfizer announced its biologics license application (BLA) for PF-05280014 has been turned down by the US Food and Drug Administration (FDA), with the agency highlighting the need for additional technical information in the CRL. The requested information does not relate to safety or clinical data, Pfizer said in a release. The news comes less than a year after…

April 26, 2018

Out with the Old, In with the New Tech as J&J Eyes CAR-T Investment

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Johnson & Johnson says it needs to invest in tech and capacity in areas like CAR-T as it looks to restructure its supply chain restructure. J&J announced the supply chain restructure as part of its first quarter 2018 financials, telling investors the action would refocus resources towards “critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio of the future.†The restructure will free between $600 and $800 million (€501 and €668 million) annually by 2022, though…

April 25, 2018