Biosimilars/Research
Challenges with implementing benefit-sharing programmes for biologicals in Europe
Diverse policies have been implemented across Europe to support the rational prescribing of biologicals. Policies limiting the reimbursement of high-cost pharmaceuticals and applying prescription quotas for ‘best-value’ biologicals (BVB) have often been combined with educational campaigns about biosimilars and with benefit-sharing (gainsharing) initiatives [1, 2].
Successful increase of biosimilar adoption in a large integrated health delivery network
Biologicals have revolutionized patient care across several therapeutic areas but are associated with significantly higher costs to patients and healthcare systems. Biosimilars offer the opportunity to reduce drug spending without compromising patient care. Medication utilization management (UM), a formulary management methodology, can be used to facilitate the adoption of biosimilars. Author Sophia Humphreys describes an innovative and strategic biosimilar adoption programme that was developed and implemented at Providence St Joseph Health [1]. Providence is a large integrated health system including 53 hospitals, 1,085 clinics and an annual drug spend of >US$1.2 billion.
Patient perspectives on biosimilars in a high uptake country
Several surveys have shown that challenges for patient acceptance of biosimilars include patients’ concerns of quality, safety, and efficacy [1-3], however, there has been lacking more in-depth knowledge of the patient perspective and the underlying rationales for such perspective. Therefore and considering Denmark has one of the highest biosimilar uptakes [4], Varma et al. [5] investigated how Danish patients with psoriasis, arthritic diseases, or inflammatory bowel disease (IBD) perceived biosimilars.
Biosimilar adoption and prescribing in Japan: a physician opinion survey
Japanese physicians regularly request information on quality, efficacy, safety and cost burden to the patient when adopting or prescribing biosimilars, demonstrates a recent survey [1]. Higher biosimilars uptake may be achievable if such information was made more accessible and digestible.
Innovent and Eli Lilly announce final results for sintilimab plus biosimilar bevacizumab injection
Innovent and Eli Lilly have announced final clinical results for their sintilimab plus bevacizumab biosimilar injection, which has been accepted by China’s National Medical Products Administration (NMPA).
Totality of evidence supporting approval of Avsola in the treatment of IBD
Avsola (ABP 710) is a biosimilar to the infliximab reference product (Remicade), a monoclonal antibody targeting tumour necrosis factor-alfa. Avsola is approved in the US and Canada for all the same indications as Remicade, including adult and paediatric Crohn’s disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis [1, 2]. Infliximab is a highly efficacious treatment for inflammatory bowel disease (IBD), which includes CD and UC. The totality of evidence (TOE) supporting the development and approval of ABP 710 was recently reviewed [3].
Amgen announces positive phase III results for ustekinumab biosimilar
Amgen has announced positive results from a phase III trial of its ustekinumab biosimilar, ABP 654. The trial met its primary endpoint, demonstrating no clinically meaningful differences with the originator product, Stelara.
Are systematic switch studies for biosimilars necessary?
A recently published review [1] questions the need for systematic switch studies to demonstrate the interchangeability of biosimilars, suggesting the studies are becoming obsolete.
Regulating drug prices in Medicare unlikely to lead to ‘revenue targeting’
A report from the American Enterprise Institute (AEI) suggests that regulating drug prices in Medicare is unlikely to lead manufacturers to compensate by increasing revenues from the commercial market, based on analysis of similar events in the European Union (EU).
Secondary patents delay access to biosimilars in the US
Biological drug patents covering new methods of manufacturing and formulation are major contributors to delays in biosimilar market entry in the US, finds a new study published in Nature Biotechnology [1].
