Global biosimilar developments of interest this week include:
Genentech and Roche commencedrecruitment for Ph III clinical trials of their ranibizumab Port Delivery System (PDS) in patients with diabetic macular edema. The PDS uses a refillable eye implant to release a ranibizumab formulation over several months.
21 Jan 2020 BioProcess International reported the launch of biosimilar adalimumab products in the US market in 2023. Drawing from an international profit erosion of 45-48% for Humira® in 2019, AbbVie's CEO Gonzalez warned stakeholders that biosimilar competition in the US would further impact profits. Gonzalez also noted that the erosion rate in the US would not be directly comparable to European markets as it would be heavily impacted by negotiations with managed care and pharmacy benefit managers.
23 Jan 2020: Janssen announcedthe UK's NICE did not recommend Stelara® (ustekinumab) for moderately to severely active ulcerative colitis, due to uncertainties over cost-effectiveness.
16 Jan 2020: Health New England, a nonprofit health plan in Massachusetts, announcedsavings of $1.7 million in the past year by reaching 93% utilisation of biosimilar infliximab
23 Jan 20: Pfizer announced the launch of its biosimilar rituximab product in the US at a 24% discount to Rituxan®. Pfizer also announced that it will launch its trastuzumab product in the US on 15 February at a 22% discount to Herceptin®.
Romania's Competition Council finedRoche $14 million for undermining biosimilar and generic competition related to MabThera® (rituximab) and Herceptin® (trastuzumab).