Insights+ Key Biosimilars Events of June 2019

Insights+ Key Biosimilars Events of May 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” which are biologically like biologics. They possess similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots have summarized key events of biosimilar space in month of June 2019. 

1. Pfenex and Alvogen Reported EMA’s Acceptance of MAA for PF708 (biosimilar teriparatide)

Date – June 01, 2019 

Product – PF708, Biosimilar Teriparatide

Pfenex and Alvogen announced that EMA has accepted MAA for its PF708, a biosimilar to Eli Lilly’s Forsteo which has generated $289M in EU & $1.6B globally in 2018 for the treatment of osteoporosis. It is expected to receive marketing authorization in all 28 states of EU, as well as in Iceland, Liechtenstein and Norway, following to the EMA approval. Teriparatide (PF708) is developed by Pfenex utilizing its Pfenex Expression Technology, pursuant to the 505(b)(2) regulatory pathway in the US and will be promoted & commercialized by Theramex in Europe.

2. Celltrion Reported Results of CT-P13 SC (biosimilar infliximab) in a Clinical Study for Rheumatoid Arthritis #EULAR2019

Date – June 11, 2019 

Product – CT-P13 SC, Biosimilar Infliximab

The study results involved assessing of CT-P13 SC (90mg/120mg/180mg) vs CT-P13 IV (3mg/kg)  in 50 patients in ratio (1:1:1:1) with RA, followed by a P-I/III study assessing CT-P13 SC (120mg, q2w) vs CT-P13 IV in 362 patients in ratio (1:1) with RA for 30wks. Collective results: @54wks. efficacy is comparable; DAS28 (CRP) and ACR20 are comparable in all cohorts; CT-P13 SC is non-inferior to CT-P13 IV, @22wks. similar ACR response, @6wk. SC 120mg safety is comparable to IV dose. CT-P13 is a mAb, currently being evaluated in an additional 5yrs. study for RA and ankylosing spondylitis and has received approval in the US (marketed as Inflectra) in Apr’16, in Europe (marketed as Remsima) in Sept’13, additionally in other 89+ countries.

3. Biogen Reported New Data of its Biosimilar Anti-TNF Portfolio at European Congress of Rheumatology (EULAR) 2019

Date – June 11, 2019 

Products – Benepali, Biosimilar Etanercept, Flixabi, Biosimilar Infliximab, Imraldi, Biosimilar Adalimumab

Biogen presented data from BENEFIT study results assessing etanercept in 533 patients with rheumatoid arthritis and axial spondyloarthritis. Additionally, it presented data from pooled analyses of etanercept, infliximab and imraldi in 1,461 patients showing similarity with its reference product @6mos. & @1yr. treatment. Biogen’s three biosimilar, Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab) are expected to save $2.04B of European healthcare system in 2019. In Feb’12, Biogen & Samsung Biologics collaborates to develop & commercialize biosimilar. Benepali (biosimilar of Enbrel), flixabi (biosimilar of Remicade), imraldi (biosimilar of Humira) received European Commission approval in Jan’16, May’16 and Aug’17 for multiple indication respectively.

4.Amgen and Allergan’s Kanjinti (biosimilar trastuzumab) Received the US FDA’s Approval for All Approved Indications of Herceptin

Date – June 13, 2019 

Product – Kanjinti, Biosimilar Trastuzumab, Herceptin  

The FDA’s approval is based on the totality of evidence which included extensive comparative analytical, pharmacokinetic and clinical data demonstrating that Kanjinti is highly similar and have no clinical differences from Roche’s Herceptin. Kanjinti is the second biosimilar from Amgen and Allergan’s collaboration and third biosimilar from the Amgen’s portfolio to receive FDA’s approval for HER2-overexpressing adjuvant & m-breast cancer and HER2-overexpressing m-gastric or gastroesophageal junction adenocarcinoma. Kanjinti is an immunoglobulin G1 kappa mAb consisting same amino acid sequence, structure and function as trastuzumab and has same dosage form & strength following reconstitution as trastuzumab.

5. Egis Pharmaceuticals Signs an Exclusive Distribution Agreement with Mundipharma for Pelmeg (biosimilar pegfilgrastim) in Central and Eastern Europe

Date – June 13, 2019 

Product – Pelmeg, Biosimilar Pegfilgrastim

Egis Pharmaceuticals acquired exclusive distribution rights of Pelmeg (pegfilgrastim, biosimilar) from Mundipharma to launch the product in four CEE markets i.e. Hungary, Romania, including Latvia and Lithuania. Pelmeg is the fourth biosimilar commercialized by Mundipharma, originally developed by Cinfa Biotech. In 2018, Mundipharma acquired Cinfa Biotech for the expansion of its footprints in biosimilars. Pelmeg is a pegylated version of G-CSF subcutaneously delivered biosimilar targeted to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy and is also approved by EU in Nov 2018.

6. Henlius Reported EMA’s Acceptance of Marketing Authorization Application for HLX02 (biosimilar trastuzumab)  

Date – June 21, 2019 

Product – HLX02, Biosimilar Trastuzumab

The acceptance followed P-III study demonstrating bio-similarity data between HLX02 and reference product trastuzumab sourced from EU in 649 patients with HER2+ m-breast cancer and P-I study resulting equivalence in PK & safety studies b/w HLX02 and reference trastuzumab sourced from both EU and China. In Jun’18, Henlius granted exclusive commercialization rights of HLX02 to Accord across 53 countries including UK, Germany in Europe. HLX02 & HLX03 (adalimumab, biosimilar) both are under NMPA review in China. HLX02 is the first biosimilar of trastuzumab developed in China, indicated for HER2+ early-stage breast cancer, HER2+ metastatic breast cancer, untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer.

7. Samsung Bioepis Reported EU Label Update with Extended Storage Conditions for Imraldi (biosimilar, adalimumab)

Date – June 26, 2019  

Product – Imraldi, Biosimilar, Adalimumab

The EU label update is based on the study examining the stability of Imraldi formulation at room temp. (25 ± 2 ˚C and 60 ± 5% relative humidity), post storing in refrigerated conditions (2-8 ˚C) for 36 mos. The separate three batches were tested at 0/2/4 wks. for solution appearance, pH, protein concentration, purity, particulates, biological activity and charge variance. The study demonstrated that the biosimilar aged to its shelf life of 36 months, is physicochemically and biologically stable for up to 4 weeks at room temperature conditions. Imraldi (adalimumab) is a mAb with EU label update to be stored in non-refrigerated conditions (up to 25˚C) up to 28 days and is already approved by EU in 2017 for RA, JIA, axSpA, psoriatic arthritis, psoriasis, including pediatric plaque psoriasis

8. Innovent and Eli Lilly Reported NMPA’s Acceptance of NDA for IBI301 (rituximab, biosimilar) for Non-Hodgkin’s lymphoma

Date – June 27, 2019 

Product – IBI301, Biosimilar Rituximab

The NDA is based on two P-III studies evaluating the safety, efficacy & PK of IBI301 vs MabThera/Rituxan (rituximab) in patients with DLBCL & CD20-positive B-cell lymphoma respectively. The two P-III studies resulting in meeting its 1EPs demonstrating the bio-similarity b/w IBI301 and branded rituximab. IBI301 is a biosimilar of rituximab targeting CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC), co-developed by Lilly and Innovent for NHL and other diseases.

9. Pfizer’s Zirabev (biosimilar bevacizumab,) Received the US FDA’s Approval for Five Types of Cancer

Date – June 28, 2019 

Product – Zirabev, Biosimilar, Bevacizumab

The approval is based on REFLECTIONS B7391003 study results assessing Zirabev vs reference product Avastin, in patients with advanced non-sq NSCLC. The study resulted in biosimilarity data, showing clinical equivalence and no clinically meaningful differences with the reference product in patients. Additionally, Zirabev is Pfizer’s second oncology biosimilar following Trazimera (trastuzumab-qyyp).    Zirabev (bevacizumab-bvzr) is a mAb inhibits formation of new blood cells (angiogenesis) approved by the US FDA for MCC, unresectable/LA/recurrent or mnon-sq NSCLC, recurrent glioblastoma, mRCC, and persistent, recurrent or metastatic cervical cancer.

10. Amgen to Withdraw the ABP 710 (biosimilar infliximab) MAA with European Medical Agency

 Date – June 28, 2019   

Product – ABP 710, Biosimilar Infliximab

The MAA’s withdrawal is in response of the change in European product strategy for ABP 710. Additionally, Amgen will focus on the resources the most value for patients can be provided. In Dec 2018, Amgen has also submitted BLA for ABP 710 to the US FDA and has two more biosimilars under development ABP 798 (rituximab, biosimilar) and ABP 959 (eculizumab, biosimilar). ABP 710 (100 mg powder) is a mAb anti-inflammatory drug targeted to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, including ankylosing spondylitis, psoriatic arthritis, and psoriasis.