Nepexto (etanercept biosimilar) / Biocon, Lupin, YL Biologics, Nichi-Iko, Viatris - LARVOL DELTA

Efficacy of switching from originator etanercept to biosimilar YLB113 in real-world patients with rheumatoid arthritis: A retrospective 12 months follow-up study. (PubMed, J Orthop Surg (Hong Kong)) - "An ROC curve analysis showed the optimal cut-off value for DAS28 at baseline to achieve remission at 12 months after switching was 2.5. RA patients who achieved remission using originator ETN, were able to maintain remission even if they switched to YLB113."

Journal • Real-world • Real-world evidence • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries (Biocon Press Release) - "Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd...announced the successful completion of the transition of the acquired biosimilars business in ~120 countries across Advanced and Emerging Markets, a year ahead of schedule....All Viatris’ biosimilar brands, including...Hulio® (bAdalimumab), Nepexto® (bEtanercept), Semglee® (bGlargine)...will now be marketed by Biocon Biologics teams, ensuring business continuity for patients, prescribers, partners, and healthcare systems."

M&A • Crohn's disease • Diabetes • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Psoriasis • Ulcerative Colitis

Lower injection-site reactions and long-term safety, immunogenicity, and efficacy of etanercept biosimilar YLB113: Results from a post-hoc analysis of a double-blind, randomized, phase III comparative study and its open-label extension in patients with rheumatoid arthritis. (PubMed, Int J Rheum Dis) - "YLB113 demonstrated long-term safety and sustained efficacy for up to 96 weeks. Patients on YLB113 experienced significantly lower ISRs and ISE in a post-hoc analysis of the phase III study when compared with reference product."

Journal • P3 data • Retrospective data • Dermatology • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] LONG TERM SAFETY AND TOLERABILITY WITH ETANERCEPT BIOSIMILAR (YLB113), RESULTS FROM A 2-YEAR OPEN LABEL EXTENSION STUDY (STUDY NO. YLB113-003) (EULAR 2021) - "The safety, efficacy and immunogenicity profile of YLB113 was maintained over the long-term through to 3 years. Switching from RP to YLB113 did not impact safety or immunogenicity."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] COMPARISON OF INJECTION SITE REACTIONS AND INJECTION SITE ERYTHEMA BETWEEN YLB113 AND ETANERCEPT REFERENCE PRODUCT FROM PHASE 3 ACTIVE COMPARATOR STUDY (STUDY NO. YLB113-002) (EULAR 2021) - "YLB113 has shown statistically significant lower incidences of ISRs (P-value <0.0001) and ISEs (P value 0.0001) compared to RP. This property may translate to a better acceptability by patients."

P3 data • Dermatology • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Mylan, Lupin Launch Etanercept Biosimilar in Germany (Center for Biosimilars) - "Lupin Limited and Mylan have launched the biosimilar etanercept Nepexto in Germany for the treatment of several inflammatory diseases."

Biosimilar launch • Immunology • Inflammation • Rheumatoid Arthritis

"Lupin and Mylan Launch Nepexto (biosimilar, etanercept) in Germany @LupinGlobal @MylanNews https://t.co/AG2aH7auZT" (@Pharmashot)

Biosimilar launch • Clinical

Lupin submits Marketing Authorization Application for etanercept biosimilar in Europe (Lupin Pharmaceuticals Press Release) - "Pharma major Lupin announced today that its Marketing Authorization Application (MAA) for a biosimilar of Etanercept has been accepted for review by the European Medicines Agency (EMA). The indications targeted for approval are Rheumatoid Arthritis (RA), Psoriatic Arthritis, Ankylosing Spondylitis, Axial spondyloarthritis, Non-radiographic axial spondyloarthritis and Plaque Psoriasis."

European regulatory • Biosimilar

Lupin's JV completes global trials for RA biosimilar (The Economic Times) - P3, N=500; "Drug major LupinBSE 0.79 % today said its joint venture with Japanese firm Yoshindo, YL Biologics, has completed global phase III trials of its Etanercept biosimilar which has met successful outcome for rheumatoid arthritis."

P3 data • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Lupin submits New Drug Application for etanercept biosimilar in Japan (Lupin Pharmaceuticals Press Release) - "Pharma major Lupin announced that YL Biologics (YLB)...in Japan has submitted a New Drug Application (NDA) for Marketing Authorization to the Pharmaceuticals and Medical Devices Agency (PMDA) for a biosimilar of Etanercept (YLB113) to treat indications for moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis....This filing also opens up other key markets like Europe, Canada, Australia, the Middle East, South East Asia and Latin America for this product. The approvals for these markets are expected within the next 12 to 18 months timeframe. The ex-US market for Etanercept is estimated at USD 4 billion in Japan and Europe along with other regulated and emerging markets. Lupin is also on course with its plans for filing in the US and is targeting a filing in FY 2019-20."

BLA • Japanese regulatory • Biosimilar

An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects. (PubMed, Eur J Drug Metab Pharmacokinet) - "A single dose of YLB113 exhibited pharmacokinetic and safety profiles comparable with those of the etanercept RP in healthy adult male subjects. Therefore, YLB113 and the etanercept RP can be considered bioequivalent. These findings support the continued development of YLB113 for use in patients with RA."

Clinical • Journal • PK/PD data

A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis. (PubMed, Rheumatol Ther) - "This study demonstrated biosimilarity of YLB113 to the RP regarding efficacy, safety, and immunogenicity in patients with moderate-to-severe RA. Based on the same mechanism of action, biosimilarity could be extrapolated to other therapeutic indications approved for etanercept."

Clinical • Journal

Lupin to launch etanercept and pegfilgrastim biosimilars the US (GaBI) - "India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar....Lupin is expecting to launch its etanercept biosimilar on the European market by July 2020, and aims to file for approval for both drugs in the US by the fourth quarter of the same year."

Biosimilar launch • NDA

Japan’s 2nd Enbrel biosimilar, Pfizer’s Herceptin follow-on get listing (Pharma Japan) - "Japan’s second Enbrel (etanercept) biosimilar by YL Biologics will join the NHI price list on May 29 along with a batch of new products that also include Pfizer’s Herceptin (trastuzumab) follow-on, the government’s official gazette revealed on May 28."

Pricing

A COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY, AND IMMUNOGENICITY OF YLB113 AND ETANERCEPT REFERENCE PRODUCT FOR THE TREATMENT OF PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS (EULAR 2019) - " A total of 528 patients with moderate-to-severe RA receiving concomitant treatment with methotrexate were randomized to receive a once-weekly dose of 50 mg of subcutaneously administered YLB113 or ETN. The present comparative study demonstrated the biosimilarity of YLB113 to ETN on the triad of efficacy, safety, and immunogenicity in patients with moderate-to-severe RA, and thus can be extrapolated to other therapeutic indications approved for ETN. The therapeutic equivalence of YLB113 and ETN in terms of the primary efficacy end point at Week 24 and long-term safety comparability until Week 52 was established with lower immunogenicity."

Clinical

New Enbrel biosimilar YLB113 is now available in Japan (Juvenile Arthritis News) - "Japanese patients with rheumatoid arthritis and juvenile arthritis can now be treated with a biosimilar therapy of Enbrel (etanercept). The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the request of YL Biologics and its collaborator Kyowa to market YLB113 as a treatment for moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis."

Biosimilar launch

Lupin gets EU GMP nod for Pune facility (The Economic Times) - "Drug major Lupin...said the company has received European good manufacturing practice (EU GMP) certificate for its Mammalian facility in Pune where Etanercept biosimilar is intended to be manufactured."

Commercial

"Lupin and YL Biologics’ Etanercept (YLB113) Receive PMDA’s Approval for Moderate-to-Severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA) in Japan @lupinlimited https://t.co/6bxPlKcBF0" (@Pharmashot)

Japanese regulatory

Lupin gains on PMDA approval for etanercept biosimilar in Japan (Moneycontrol) - "Lupin shares gained more than 1 percent intraday on March 26 after its joint venture company received PMDA approval for Etanercept biosimilar in Japan....The approval to treat moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis was received on March 26, it added."

Japanese regulatory