Insights+ Key Biosimilars Events of August 2019

Insights+ Key Biosimilars Events of May 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million of lars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space in the month of August 2019.

1. Mylan and Biocon Launched Ogivri (biosimilar, trastuzumab) in Australia

Date – Aug 01, 2019

Product – Ogivri, Biosimilar Trastuzumab, Herceptin

Shots:

  • Ogivri is the first biosimilar to Herceptin (trastuzumab) to be approved and launched in Australia for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer and will be available on the Pharmaceutical Benefits Scheme
  • The TGA’s approval of Ogivri is based on data that demonstrated bio-similarity to Herceptin with no clinically meaningful differences in efficacy, safety, purity, and potency. The HERITAGE study resulted in bio-similarity in terms of reduction in tumor size @24 wks. & OS @48 wks.
  • Ogivri is a biosimilar of Roche’s Herceptin and has received FDA’s approval in Dec’2017 for HER2-overexpressing breast or metastatic stomach cancer, gastric or gastroesophageal junction adenocarcinoma

2. United Healthcare Preferred Amgen’s Two Anticancer Biosimilars in Upcoming October 2019

Date – Aug 15, 2019

Products – Mvasi, Biosimilar Bevacizumab, Kanjinti, Biosimilar Trastuzumab, Zarxio, Biosimilar Filgrastim, Inflectra, Avastin

Shots:

  • United Healthcare planned to utilize Amgen’s Mvasi (biosimilar, bevacizumab) and Kanjinti (biosimilar, trastuzumab) as preferred products for commercial and community plans (but not Medicare Advantage)in Oct’2019 , while with no longer favorability to reference products Avastin and Herceptin
  • Additionally, on Oct 1, 2019 Sandoz’s Zarxio (biosimilar, filgrastim) will be listed as preferred product before use of follow-on filgrastim (Granix), brand-name filgrastim (Neupogen), or Pfizer’s biosimilar product (Nivestym) and also preferred Celltrion & Pfizer’s biosimilar (Inflectra), and Samsung Bioepis & Merck’s biosimilar (Renflexis) over brand name infliximab (Remicade)
  • Genentech’s Avastin (bevacizumab) is a mAb, targeted to treat multiple indications of cancer. Herceptin (trastuzumab) is a mAb that can be administered as an IV or as a SC infusion which binds to HER2 receptors present on the surface of HER2-positive tumor cells

3.STADA Launched its Movymia (biosimilar, teriparatide) to Treat Osteoporosis in 24 Countries

Date – Aug 16, 2019

Product – Movymia, Biosimilar Teriparatide

Shots:

  • In early H2’19, STADA launched its biosimilar teriparatide, Movymia as a cost-effective treatment with the patent expiration of the reference product Forsteo leading to an expansion of STADA’s biosimilar portfolio in the EU
  • Forsteo is a form of parathyroid hormone used to make the bones stronger and to reduce the risk of fractures by stimulating bone formation & has produced sales of €250M in a year in the EU
  • Movymia is a re-fillable multidose injection device called Movymia Pen used for the treatment of osteoporosis plus it is the only active ingredient approved for osteoanabolic therapy

4.Federal Circuit Dismissed the Motion to Halt Sales of Amgen’s Mvasi (biosimilar, bevacizumab-awws) in the US

Date – Aug 16, 2019

Product – Mvasi, Biosimilar bevacizumab-awws

Shots:

  • The US FDA approved Amgen’s Mvasi in Sept’2017 with its notice of commercial marketing to Genentech in Oct’2017 and indicated its launch post 180 days after the letter’s date
  • Amgen filed no. of supplements in accordance of its BLA with the FDA, including changes to the labeling for the biosimilar while Genentech addressed it as a different product approved in reference to its US FDA approval of 2017, further prohibited Amgen from marketing the biosimilar until 180 days post-filing a new notice of commercial marketing
  • The Federal Circuit dismissed the motion addressing Genentech that the original product approved was same as the product for which supplements to the BLA were also approved. Additionally, Genentech appealed for an injunction on sales of Mvasi in the US on which the Federal Circuit explained the four factors of injunction leading to disagreement halting sales of Amgen’s Mvasi

5. Samsung Bioepis Initiated Recruitment of Patients in P-III Study for SB12 (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH) in India

Date – Aug 16, 2019

Products – SB12,Biosimilar Eculizumab

Shots:

  • The P-III study involved assessing of SB12(600/900 mg, IV) vs Soliris (eculizumab, 600/900 mg, IV) in 50 patients with PNH, evaluated the efficacy, safety, immunogenicity and PK
  • The primary outcome of the study was to measure hemolysis by lactate dehydrogenase @26wks. parallel comparison and @52wks. by crossover comparison, with its expected completion in Jul’2021
  • SB12 is a biosimilar to Soliris targeted for paroxysmal nocturnal hemoglobinuria. Soliris is mAb, approved by the US FDA for treat atypical hemolytic uremic syndrome, myasthenia gravis and neuromyelitis optica spectrum disorder

6. Gedeon Richter Launched Terrosa (biosimilar, teriparatide) in Europe  

Date – Aug 20, 2019

Product – Terrosa, Biosimilar Teriparatide

Shots:

  • Richter has launched Terrosa, a biosimilar to Eli Lilly’s Forsteo approved for osteoporosis in postmenopausal women and in men at high risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture
  • Richter launched Terrosa through its affiliates in Europe following the patent expiration of the Forsteo in Aug’ 2019. The in-vivo non-clinical studies and the clinical study demonstrated bio-similarity data to Forsteo
  • Terrosa is a biologically active fragment of the human parathyroid hormone which replaces the natural hormone thus stimulating bone formation and has received EC’s approval in Jan’2017 following CHMP’s positive opinion

7. Celltrion and Teva Reported Updated Results of CT-P6 in P-III Study for Patients Receiving Neoadjuvant Treatment for HER2-Positive Early Breast Cancer

Date – Aug 21, 2019

Product – CT-P6, trastuzumab

Shots:

  • The study involved assessing of CT-P6 vs reference trastuzumab in 516 patients’ neoadjuvant period of the study entered the adjuvant treatment periodThe study resulted in 9 patients (3.3%) in the biosimilar group and 6 patients (2.2%) in the reference group in the ITT population had recurrent or progressive disease @1year
  • In adjuvant period relative dose intensity of trastuzumab was 98.5% (2.97) and 98.8% (2.27) in the biosimilar and reference groups respectively
  • CT-P6 is a mAb, targeted for a protein designed to recognize and bind to a specific structure or antigen in the body and is targeted to treat Neoadjuvant Treatment for HER2-Positive Early Breast Cancer

8. Biocon Receives EU’s GMP Certification for its Semglee (biosimilar, Insulin Glargine) Manufacturing Facility in Malaysia

Date – Aug 22, 2019

Product – Semglee, Biosimilar Insulin Glargine

Shots:

  • Biocon received EMA’s certificate of GMP compliance from European inspection authority, Health Products Regulatory Authority (Ireland) and expanded its capacities multi-fold with the new large-scale device facilities for meeting needs of patients with diabetes in EU
  • The manufacturing facility at Malaysia was inspected in May’2019 leading to Asia’s largest integrated insulin facility manufacturing Drug Substance and Drug Products in vials, cartridges, and insulin delivery devices including recombinant human Insulin (rh-Insulin) and Insulin Glargine
  • Biocon & Mylan’s Semglee, a biosimilar to Sanofi’s Lantus is an approved therapy in 60+ countries including its EMA’s approval in Mar’2018 and became available in key EU markets by Mylan since Nov’2018

9. Amgen and Allergan Reported Results of ABP 798 (biosimilar, rituximab) in JASMINE Study for Non-Hodgkin’s Lymphoma

Product – ABP 798, Biosimilar Rituximab

Shots:

  • The JASMINE study involved assessing of ABP 798 vs its reference product, Rituximab at a dose of 375 mg/m2 (IV, qw) for 4wks. followed by dosing at weeks 12 and 20 in 256 patients with non-Hodgkin’s lymphoma
  • The JASMINE study resulted in demonstrating bio-similarity data in its 1EPs i.e, ORR @28wks. and clinical equivalence to Rituxan. Additionally, the companies conducted a clinical study of ABP 798 in mod. to sev. RA patients and resulted in clinical equivalence & PK similarity
  • ABP 798 is an anti-CD20 mAb, having the same amino acid sequence as the reference product, Rituxan. In Dec 2011, Amgen and Allergan entered into a WW collaboration to develop & commercialize four oncology antibody biosimilar therapies

10. Conglomerate of Rheumatology and Spondylitis Organizations Released New Updated Guidelines Against Mandatory Switching to Biosimilars

Date – Aug 22, 2019

Products – Biosimilars

Shots:

  • The newly updated guidelines are being built on previous recommendations based on best practices for imaging, managing biologic, biosimilars usage in patients, and providing information on the medication
  • The guidelines included 20 clinical questions based on pharmacological treatment indicated in 2015 guidelines and 26 new questions on the pharmacological treatment treat-to-target strategy with the use of imaging in addition to the rate voting panel and labeled recommendations
  • Additionally, the guidelines also included recommendation against mandatory switching to biosimilar as a first anti-TNF treatment in patients whose disease was still active as the biosimilar will have the same response as the original one

11. Mylan Made Amendments in its 2018 License Agreement with Revance for Biosimilar of BOTOX  

Date – Aug 22, 2019

Products – BOTOX, OnabotulinumtoxinA

Shots:

  • Mylan paid $5M up front in addition to $25M (according to 2018 deal), contingent payments ~$100M, ~$225M milestones on the achievement of specified clinical and regulatory milestones and royalties on sales of the biosimilar in Mylan territories
  • The amendment was made in the extension of time for Mylan to develop and commercialize biosimilar of BOTOX (onabotulinumtoxinA). Additionally, Mylan must inform Revance by Aprl’20, or 30 days before the date that the Company provides Mylan with certain deliverables
  • BOTOX (onabotulinumtoxinA) is a neuromuscular agent, approved for incontinence caused due to neurological conditions, prophylaxis of headache in patients with migraine, upper limb spasticity, cervical dystonia, and strabismus

12. Innovent Biologics Reported Results of IBI303 (biosimilar, adalimumab) in P-III Studies for Ankylosing  Spondylitis

Date – Aug 30, 2019

Product – IBI303, Biosimilar Adalimumab

Shots:

  • The P-III study involved assessing of IBI303 (SC, 40 mg/0.8 ml, q2w) vs the reference product, Humira (adalimiumab) in 438 patients with ankylosing spondylitis across 20 hospitals in China
  • The P-III study resulted in meeting its 1EPs, @24wks. ASAS20 response rate (75% vs 72%) & 2EPs i.e, ASAS20 @12wks., ASAS40 @24wks; ASAS partial response rates, ASAS5/6 response rate, and BASDAI and were published in The Lancet Rheumatology
  • IBI303 is a mAb of TNF-alpha having the same amino acid sequence, showing a high degree of biosimilarity data to the reference product, AbbVie’s Humira and has received NMPA’s Priority Review for its NDA