Insights+ Key Biosimilars Events of October 2019

Insights+ Key Biosimilars Events of May 2019

Biosimilars are key alternatives for costly Biologics therapies and saving millions of dollars 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 the biosimilar space of October 2019.

1. Pfizer Launched its Zirabev (biosimilar, bevacizumab) in the US by the year-end 2019  

Date – Oct 01, 2019

Product – Zirabev (biosimilar, bevacizumab)

  • The biosimilar launched in the US on Dec 31, 2019 following the settlement between Genentech and Pfizer granting all global rights of the product to the Pfizer. In Sept 2019, Genentech and Pfizer signed a joint stipulation of dismissal in their patent litigation case and voluntarily dismissed all the claims and counterclaims of April 2019 complaint
  • Genentech alleged that Pfizer had not produced all necessary information concerning Avastin, and claimed that the biosimilar would infringe 23 of its patents
  • Zirabev (bevacizumab-bvzr) is a mAb inhibits formation of new blood cells (angiogenesis) approved by the US FDA in Jun’2019 for MCC, unresectable/LA/recurrent or mnon-sq NSCLC, recurrent glioblastoma, mRCC, and persistent, recurrent or metastatic cervical cancer and also received EC’s approval in Feb’2019  

2. Biocon and Mylan Launched Semglee (biosimilar, Insulin Glargine) in Australia

Date – Oct 03, 2019

Product – Semglee (biosimilar, Insulin Glargine)

  • Biocon & Mylan launched the Semglee (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen) as the first Insulin Glargine biosimilar in Australia available on the PBS
  • The TGA approval was based on the data demonstrating high bio-similarity of Semglee with the reference, Insulin Glargine. The launch of Semglee will increase patients access to the therapy and reduces the cost burden for PBS
  • Insulin glargine (qd) is a long-acting basal insulin analog, helps to control the blood sugar levels in diabetes and is one of the three insulin analogs being co-developed by Mylan and Biocon. Mylan holds exclusive commercialization rights of Semglee in the US, Canada, Australia, New Zealand & EU while Biocon grasps exclusive commercialization rights in Japan & few emerging markets with co-exclusive commercialization rights with Mylan in ROW

3. Alvogen and Pfenex’s PF708 (biosimilar, teriparatide) Received FDA’s Approval for the Treatment of Osteoporosis

Date – Oct 07, 2019

Product – PF708 (biosimilar, teriparatide)

  • The US FDA has granted approval to PF708, a biosimilar of Eli Lilly’s Forteo (teriparatide injection) under the 505(b)(2) regulatory pathway for the treatment of osteoporosis in certain patients at high risk for fracture
  • Pfenex received $2.5M milestone from Alvogen on its approval in the US. The PF708 is the first approved product of Pfenex, validating Pfenex Expression Technology platform and enhances patient’s access to a cost-effective alternative to Forteo
  • Pfenex was conducting a comparative human factors study between PF708 and Forteo, evaluated the therapeutic equivalence of both the therapies with its anticipated submission by the end of Oct’19

4. Samsung Bioepis Reported Real-World Data of Benepali (biosimilar, etanercept) in Patients with Psoriasis at EADV 2019

Date – Oct 09, 2019

Product – Benepali (biosimilar, etanercept)

  • The study enrolled BADBIR-registered patient treated with Benepali from Jan 01, 2016 to Sept 01, 2018. BADBIR is a UK and Ireland observational study assessing long-term safety of biologic treatments for psoriasis while Samsung Bioepis participated in it since May 2016
  • The mean disease duration was 22.6 yrs., PASI and DLQI scores 11.6 and 13.1 respectively, median treatment period 14.1 months. In 48 patients with PASI score at baseline and 6 mos. PASI < 10 (N=20, mean PASI 3.2) no increment after 6 mos. and PASI ≥ 10 (N=28, mean PASI 15.7) reduced after 6 mos. (mean PASI 5.0)
  • Benepali (biosimilar, etanercept) referencing Enbrel is an anti-TNF biosimilar approved by EC in Jan 2016, for moderate to severe RA, JIA, PsA, axSpA  (ankylosing spondylitis and non-radiographic axial spondyloarthritis), and plaque psoriasis and is available in 25 countries in EU plus most prescribed across France, Germany, Italy, Spain, and the UK combined

5. Biocon Biologics Signed an In-License Agreement with Just – Evotec Biologics

Date – Oct 11, 2019

Product – Biosimilars

  • Biocon Biologics performed all end-to-end development activities, IND filing, manufacturing and commercialization post-regulatory approval in its own authorized global markets for assets and will utilize Just – Evotec Biologics’ expertise in process development domain mainly in optimized manufacturability
  • Just – Evotec Biologics received license fee plus development, regulatory and commercial milestone payments. The focus of the agreement was to expand Biocon Biologics’ biosimilar portfolio with the addition of Just – Evotec’s pre-clinical candidates and utilizing their late-stage development, manufacturing and commercial capabilities plus technology for further development
  • Biocon Biologics has pipeline of 28 candidates including 11 with Mylan some with Sandoz and focusses to develop therapies in diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology, and inflammatory diseases  

6. NeuClone Reported Dosing of NeuLara (proposed biosimilar, ustekinumab) in P-I Trial    

Date – Oct 17, 2019

Product – NeuLara (proposed biosimilar, ustekinumab)

  • Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme is responsible for conducting the NeuLara P-I trial and is being conducted across 200 healthy volunteers assessing PK and safety of US- and EU-sourced Stelara
  • NeuClone’s NeuLara is the second biosimilar in pipeline to enter in clinical development and is developed in partnership with Serum Institute of India
  • NeuLara is a mAb targeting interleukin-12 and -23 developed to treat patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis 

7. Mundipharma’s Pegfilgrastim Mundipharma (biosimilar, pegfilgrastim) Received CHMP Positive Opinion for MAA in EU  

Date – Oct 18, 2019

Product – Pegfilgrastim Mundipharma

  • The Mundipharma biosimilar Pegfilgrastim Mundipharma (6mg solution injection) will be authorized for sales in the EU for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy
  • In Nov’2018, Mundipharma has received EC’s approval with trade name Pelmeg having same indication & same dose, which also get CHMP’s positive opinion based on the comparability study of pharmacodynamics and immunogenicity with Neulasta
  • The commercialization of Pelmeg in the EU raises the question that Pegfilgrastim Mundipharma fits in the company’s business strategy. Mundipharma did not respond to clarify whether Pegfilgrastim Mundipharma is a separately developed product or a duplicate of Pelmeg

8. Alvogen Signed an Exclusive Commercialization Agreement with Three Pharma Companies for PF708 (biosimilar, teriparatide)

Date – Oct 21, 2019

Product – Biosimilars

  • Alvogen collaborated with PharmBio, Kamada and Jamp to commercialize PF708 for the treatment of osteoporosis in South Korea, Israel, and Canada respectively
  • The focus of the collaboration was to build strong commercial networks in South Korea, Israel and Canada and to gain commercial expertise within the territories
  • PF708 is a biosimilar referencing Eli Lilly’s Forteo/ Forsteo, being developed pursuant to the 505(b)(2) regulatory pathway in the US and has received FDA’s approval in Oct’2019. Alvogen in partnership with Saja has submitted MAA for PF708 to the Kingdom of Saudi Arabia’s Saudi Food and Drug Authority

9. WHO Signed MoU with IGBA for Promoting the Access to Biosimilars and Generics

Date – Oct 24, 2019

Product – Biosimilars

  • The memorandum of understanding signed between WHO and International Generic and Biosimilar Medicines Association was to facilitate the approval of generics and biosimilars thus reducing the burden of clinical trials for biosimilars and increases the access to drugs
  • The WHO’s efforts was to increase the access to Biosimilar includes List of International Comparators, providing information on reference products that can be used in clinical studies and its prequalification program, assessing the quality, safety, and efficacy of medicinal products
  • The independent study by McKinsey estimated that WHO prequalification saves the world up to $590M/year. Additionally, WHO provides Biowaiver List which describes generic medicines that are eligible for a waiver from studies

10. Formycon Reported Initiation of P-I Trial for FYB202 (biosimilar, ustekinumab)

Date – Oct 28, 2019

Products – FYB202 (biosimilar, ustekinumab), Stelara

  • The P-I study involved assessing of FYB202 vs Stelara in patients evaluating the PK, safety, and tolerability while their dosing has been started last week
  • Bioeq GmbH sponsored the trial and will take care of study design and clinical operation FYB202 is developed in a joint venture between Aristo Pharma GmbH and Formycon AG
  • FYB202 is a mAb targeting cytokines interleukin-12 and interleukin-23 used for the treatment of several different serious inflammatory diseases, such as moderate to severe psoriasis including UC, Crohn’s disease and psoriatic arthritis 

11. Pfizer Reported Launch Date for its Two Anticancer Biosimilars

Date – Oct 29, 2019

Products – Trazimera (biosimilar, trastuzumab), Ruxience (biosimilar, rituximab)

  • Pfizer’s two anticancer biosimilar Trazimera and Ruxience will be launched in Jan 2020, while the other in Feb 2020 respectively
  • Ruxience (biosimilar, rituximab) was approved in July 2019 targeted for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis while Trazimera (biosimilar, trastuzumab) received approval in Mar’2019 for HER2-positive breast cancer and metastatic gastric cancer  
  • Ruxience (rituximab-pvvr) is a mAb designed to target CD20 protein and is Pfizer’s third oncology biosimilar approved by the US FDA in 2019 with EMA’s awaited approval. Trazimera (trastuzumab-qyyp) is a mAb designed to target HER2 protein and has been evaluated in 500 patients in 20+ countries to date

12. Pfenex Reported Results of Human Factors Study for its PF708 Candidate (biosimilar, teriparatide)

Date – Oct 29, 2019

Products – PF708 (biosimilar, teriparatide), Forteo

  • The follow on study involved assessing of PF708 vs Forteo in 102 patients including 52 with osteoporosis and 50 with caregivers
  • The study demonstrated PF708 had fewer or equal user errors showing 33% and 17 % of critical tasks respectively further concluded that the study data of user interface of the FDA-approved PF708 product is non-inferior to that of Forteo
  • PF708 is a mAb approved by the US FDA for treatment of osteoporosis in certain patients at high risk for fracture and is filled with RMA under biosimilar pathway referencing Forsteo