Momenta seems to be in final preparations for its first 351(k) filing to the Food and Drug Administration (FDA). In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval. Despite this promising news, Momenta is facing strong headwinds. Even if it gains … Continue reading An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?
Tag: Humira
Fujifilm Gains Further Exposure in Biosimilar Partnerships
The biosimilar industry continues to make strange bedfellows. In July 2016, I reported in the Center for Biosimilars that a subsidiary of the Japanese camera maker, Fujifilm, had jumped into the biosimilar field. The Indian pharmaceutical company Biocon announced that it has launched its new insulin glargine biosimilar in Japan. Fujifilm Pharma Co, Ltd was … Continue reading Fujifilm Gains Further Exposure in Biosimilar Partnerships
With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
Samsung Bioepis and Biogen has reached a deal with Abbvie that would enable it to market its biosimilar adalimumab (should it be granted approval) in June 2023. This is the second deal Abbvie has made with a potential competitor, confirming the solidity of its patent wall. The European patent expires in October 2018, and competitors … Continue reading With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?
AbbVie executives are sticking to their pledge to restrict annual price increases on Humira® below 10%, but even payer price protections won’t mitigate the increasing expenditures before adalimumab biosimilars hit the market. In 2023, when adalimumab biosimilars become available, the savings biosimilars represent may not be real savings at all. Pharmaceutical companies generally seek to … Continue reading What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?
Sandoz Files 351(k) Application for Adalimumab Biosimilar
Sandoz announced that it has thrown its hat in the ring for another Humira biosimilar. Sandoz filed an European application for approval for GP2017 last year, in the expectation that it will be able to launch soon after the European patent expires in October 2018. This will be the third application for an adalimumab biosimilar. … Continue reading Sandoz Files 351(k) Application for Adalimumab Biosimilar
Sandoz’s Pegfilgrastim Biosimilar Under New Review at EMA
On October 27, Sandoz announced that the European Medicines Agency has accepted its re-application for review of its biosimilar version of Neulasta® as supportive treatment in patients receiving cytotoxic chemotherapy. Sandoz’s attempt to bring its biosimilar pegfilgrastim to the market was stalled in the US in Q2 2016, when the FDA issued a complete response … Continue reading Sandoz’s Pegfilgrastim Biosimilar Under New Review at EMA
Are We Now Thinking “Authorized Biosimilars”?
Authorized generics have been around for a couple of decades. They can be a challenge to payers, health systems, and patients who are seeking the price-reduction benefits borne out of normal competition. The Amgen–Abbvie agreement on the biosimilar for Humira® seems to be right out of this playbook.
The Week in Biosimilar News
You know it’s been a pretty desperate week in the biosimilar blogosphere when twitter feeds relate back to articles published in January, rehashes of the US Supreme Court decision in June, or yet another estimate of the savings potentially ascribed to biosimilar use (based on erroneous assumptions). However, there were a few significant tidbits announced last week that are worth reviewing.
FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route
Boehringer Ingelheim Pharmaceuticals, Inc. announced August 29 that it had received approval from the Food and Drug Administration (FDA) for its first biosimilar. Named Cyltezo™ (adalimumab-adbm), a biosimilar to Humira®, it is approved for several autoimmune disorders, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease in adults, plaque psoriasis, and … Continue reading FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route
Budgeting the Impact of Inflectra and a Possible Clinical Benefit for Amjevita
The model assumed 3 levels of discounting on Remicade: 10%, 15%, and 20%. They assumed that 60% of patients with a gastrointestinal indication would start on Remicade, and 40% of new start patients would be given Inflectra.