Roche Withdraws SLP Against Biocon and Mylan's Trastuzumab Biosimilar
August 14th 2017Roche has withdrawn its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.
Clinical and Cost Effectiveness in Switching From Innovator to Biosimilar Infliximab
August 12th 2017The Canadian Agency for Drugs and Technologies in Health reviewed the clinical effectiveness, cost-effectiveness, and advice from guidelines concerning switching from innovator to biosimilar infliximab for the treatment of several autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis.
ACA Uncertainty Gives Rise to Stark 2018 Premium Changes
August 11th 2017Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.
TARGET Trial: Sarilumab Improves PROs in Rheumatoid Arthritis
August 10th 2017A recently published study demonstrates that sarilumab improves patient-reported outcomes in patients with rheumatoid arthritis who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.
GP2013 Bioequivalent With Reference Rituximab in RA
August 10th 2017A recent international, randomized, double-blind study comparing the proposed biosimilar GP2013with both the reference rituximab approved in the European Union and in the United States found that GP2013 demonstrated 3-way pharmacokinetic and pharmacodynamic equivalence with both products in patients with rheumatoid arthritis.
Industry Experts: The Patent Dance Still Has Value, But Uncertainty Lies Ahead
August 9th 2017The US Supreme Court’s recent ruling in the case of Sandoz v Amgen led to industry speculation that biosimilar applicants could lack incentive to participate in the information exchange process with reference product sponsors, or the so-called “patent dance,” provided for under the Biologics Price Competition and Innovation Act (BPCIA).
Coherus Petitions for IPR of Key Etanercept Patent
August 9th 2017Coherus BioSciences announced this week that it has filed a petition for inter partes review of a key patent protecting Amgen’s etanercept (Enbrel). Patent 8,163,522 (also known as the ‘522 patent) concerns a process for isolating non-soluble proteins.
Pharmacist Sees Cost, Programs, Safety as Key Payer and Provider Concerns With Biosimilars
August 8th 2017Kyle F. Skiermont, PharmD, COO of Fairview Pharmacy Services, spoke with The Center for Biosimilars® about his experience with payers and providers as they prepare for the impact of biosimilar drugs and possible non-medical switching.
Anti-TNF Agents Improve Outcomes, Raise Risks in East Asian Patients With IBD
August 8th 2017The introduction of anti-tumor necrosis factor-alpha agents has improved treatment options for patients with inflammatory bowel disease. However, these agents can also lead to increased vulnerability to infections, development of autoimmune diseases, malignancies, and decreased immunogenicity of vaccinations.
FDA Inspection Notes 10 Problems With Biocon's Manufacturing Facility
August 8th 2017The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.
Some Consumers Must Buy Brand Name Drugs, Not Generics
August 8th 2017Contradicting standard advice given to most patients that the preferred medication is a less-expensive generic medication, rather than a brand-name drug, some health insurers are telling consumers the opposite: they must buy brand-name drugs even when cheaper generics are available.
Eye on Pharma: Regeneron and Sanofi Terminate Antibody Discovery Agreement
August 8th 2017New York-based Regeneron has announced that it will allow one of its key partnerships with the French drug maker Sanofi to terminate at the end of the year without an extension. The companies’ Antibody Discovery Agreement was responsible for the discovery and development of such drugs as alirocumab (Praluent), dupilumab (Dupixent), and sarilumab (Kevzara).
Review Highlights Lessons Learned from 4 Biosimilar Approvals
August 7th 2017The FDA’s biosimilar pathway has encouraged a robust product pipeline, but the fact that few biosimilar drugs have been approved by the agency thus far means that there is still some industry uncertainty on the FDA’s approach to this class of products.
AbbVie Files Complaint Against BI in New BPCIA Litigation Over Humira
August 5th 2017AbbVie is engaged in new litigation over its blockbuster adalimumab (Humira). This week, the drug maker filed suit against Boehringer Ingelheim in a Delaware federal court, saying that BI will infringe on 74 of its patents for adalimumab in its development of a biosimilar product, BI 695501.
Developing the Totality of Evidence for Biosimilarity
August 4th 2017The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.
Amjevita Similar to Humira in Efficacy, Safety, and Immunogenicity in RA
August 3rd 2017A recently published study shows that Amgen’s ABP 501 (Amjevita), referenced on Humira, shows that the product has similar efficacy, safety, and immunogenicity to its reference in patients with moderate to severe rheumatoid arthritis.
Biosimilars Lead to Lower Q2 Sales for Sanofi, Muted Success for Pfizer
August 2nd 2017Sanofi’s 2017 second-quarter sales from its diabetes and cardiovascular business declined by 15% relative to the same sales quarter last year, the French drug maker reported on Monday. Sanofi cited biosimilar competition in Europe as well as exclusion from US formularies as the chief reasons for its steep sales decline.