Sandoz, announced that EMA has accepted their Marketing Authorization Application for its biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF).

Sandoz is seeking approval for the same indication as the reference product.

Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. It reduces the duration of neutropenia and the incidence of febrile neutropenia that are a result of their chemotherapy treatment. The incidence of febrile neutropenia occurring with common chemotherapy regimens is 25 to 40% of treatment-naive patients.

“Sandoz is the leading provider of daily G-CSF in Europe and the regulatory filing of our biosimilar pegfilgrastim further cements our commitment to patients undergoing cancer treatment” said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz.  “If approved, physicians in the EU will have another high-quality Sandoz biosimilar treatment option for patients needing granulocyte colony-stimulating factors” McCamish continued.

Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials – one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients – is expected to satisfy the regulatory requirements for demonstrating high similarity to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product’s indication.

Source: Sandoz Press release

The trastuzumab biosimilar, to be marketed under the trade name HERtiCAD, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body.

The market authorization of the trastuzumab biosimilar (fully developed and produced by BIOCAD) followed the results of a randomized multicenter clinical study comparing the pharmacokinetics, immunogenicity, safety, and efficacy of BCD-022 (trastuzumab biosimilar) to the innovator Herceptin (F. Hoffmann-La Roche Ltd).

Dmitry Morozov, founder and CEO of Biocad, said, “In 2014, world sales of the original drug trastuzumab were over $6.8 billion. Russia’s government spent over 5 billion rubles (130 mln USD) for original medicine and there are still uncovered medical need of Russian patients in trastuzumab. The approval of trastuzumab biosimilar is definitely good news for patients who previously had limited access to advanced therapeutics, and in particular for those hindered by the extra high cost of antibody biopharmaceuticals.

Biocad’s trastuzumab biosimilar is produced in a new, ultra-modern Neudorf facility set in a special economic development district outside St. Petersburg. The company has already registered two other biosimilars of rituximab and bevacizumab. Rituximab was the first mAb biosimilar approved in Russia under the trade name Acellbia and by now used in more than 6 000 patients with non-Hodgkin’s lymphoma and chronic lymphoid leukemia under federal reimbursement.

The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for Benepali, an etanercept biosimilar referencing Enbrel.

Benepali^® has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make Benepali available for patients in the coming weeks.

Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there. Anti-TNF’s are the largest component of the EU biologics market, accounting for approximately $10 billion of all biologics sold there.

The EC approval was based on a robust preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics, technical development and manufacturing expertise. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared Benepalito its reference product Enbrel. The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe RA despite methotrexate therapy, across more than 70 sites in 10 countries to receive Benepali or Enbrel in a 1:1 ratio. Analysis of the primary endpoint showed that Benepali  had equivalent efficacy to Enbrel, as shown by an ACR20 response at week 24 of 78.1% in the Benepali arm versus 80.3% in the Enbrel arm. Further analysis at 52 weeks confirmed comparable efficacy as shown by an ACR20 response of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel throughout the study.

Source: Biosimilar News

Amgen announced the submission of a Biologics License Application (BLA) with the United States FDA for ABP 501, a biosimilar candidate to Humira (adalimumab).

Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen’s first BLA submission using the 351(k) biosimilar pathway.

“The submission of Amgen’s first biosimilar application to the FDA is an exciting milestone, expanding our inflammation portfolio to provide additional therapeutic options to patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen’s branded biologic medicines and biosimilars are developed and manufactured according to the same high standards, and we are committed to delivering high-quality medicines to patients with serious inflammatory diseases.”

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-alfa monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.

Amgen’s BLA submission includes analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

Source: Biosimilar News

Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali – a biosimilar version of Enbrel^® (etanercept).

The drug, previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. This marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar.

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Benepali^®. If a marketing authorization is granted, Benepali will be the first etanercept biosimilar to be approved in the European Union (EU).

“We are very pleased to have developed the first etanercept biosimilar to receive a positive CHMP opinion,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “By leveraging our strengths in product development and quality assurance, we will continue to focus on developing affordable, high-quality biologic treatment options for patients in Europe who need these life-enhancing medications.”

This positive CHMP opinion on Benepali was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Benepali to Enbrel. In the 52-week Phase 3 clinical study, which involved 596 patients randomized across 70 sites in 10 countries, Benepali demonstrated comparable safety and equivalent efficacy to Enbrel, as evidenced in ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm.

Source: Biosimilar News

Cinfa Biotech S.L., the biosimilars company of Infarco group, today announced that the first subjects have been dosed in a clinical trial of B12019, a biosimilar version of Neulasta(R) (pegfilgrastim) to treat chemotherapy-induced neutropenia. B12019 is a pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist, which is used to stimulate bone marrow to produce more neutrophils to decrease the incidence of infections in patients undergoing chemotherapy.

B12019, the lead development program of Cinfa Biotech, has completed preclinical studies, and the manufacturing process (GMP) for B12019 has been implemented at commercial scale. This trial is the first part of a clinical development program investigating the clinical comparability of B12019, which has been designed based on the longstanding expertise of Cinfa Biotech’s team in developing biosimilars.

The single dose, cross-over study will enrol up to 170 healthy volunteers in Germany. It primarily investigates the pharmacokinetics (PK) and the pharmacodynamics (PD) of B12019 as compared to Neulasta(R). The study design is based on scientific advice from the European Medicines Agency (EMA) and is tailored to the specific properties of pegfilgrastim.

Epirus Biopharmaceuticals, Inc., announced an agreement for the acquisition of Bioceros Holding B.V., enabling Epirus to expand its biosimilar pipeline and vertically integrate product development capabilities.

From the Bioceros platform, Epirus will expand its pipeline with the addition of three preclinical product candidates: BOW080, a proposed biosimilar to eculizumab (reference biologic Soliris); BOW090, a proposed biosimilar to ustekinumab (reference biologic Stelara); and BOW100, a proposed biosimilar to golimumab (reference biologic Simponi).  Soliris, marketed by Alexion Pharmaceuticals, is currently indicated to treat ultra-rare blood disorders, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).  Simponi and Stelara are marketed by Janssen Pharmaceuticals and indicated in inflammatory and immune mediated disorders.

These three new pipeline assets represent a global growth opportunity for Epirus in targeting reference biologics with estimated 2020 peak sales of $12 billion.  The platform also enables future pipeline growth opportunities for Epirus.  The anticipated filing dates for the three new pipeline products are 2020 for BOW080, 2021 for BOW090 and 2022 for BOW100.

Source: Epirus Press release

Intas Pharmaceuticals has launched Razumab™, its biosimilar to Lucentis® (Ranibizumab).

Intas is the first company globally to develop and launch a biosimilar version of Ranibizumab. Razumab is manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus reducing the risk of contamination during use.

Ranibizumab is a therapeutic antibody fragment designed specifically for treating degenerative conditions of the eye. Ranibizumab is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD), a common degenerative condition of the eyes in the elderly. It is also indicated for Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy in patients with Diabetic Macular Edema and vision loss resulting from choroidal neovascularization in pathologic myopia (mCNV).

“Intas’ Ranibizumab, Razumab™ is a 100% ‘Made In India‘ molecule, a feat achieved by the scientists at Intas and unparalleled till date. With the mission to provide global healthcare at affordable costs, Razumab will be about 25% cheaper than the imported Lucentis in the hand of the patient. Our objective is to make the treatment available to a wider patient pool, that is as yet denied treatment due to the high cost of imported Lucentis,” said Mr.Binish Chudgar, the Vice Chairman of the Company.

Razumab is the tenth biosimilar launched by Intas in India, by far the largest number of indigenously developed biosimilars by any company. Since 2004, when Intas launched its first biosimilar, Intas has constantly worked to bring the latest in biological therapies to Indian patients at affordable prices. With its robust pipeline of future products under development, Intas aims to continue on this endeavor.

Source: Intas Press release

Sandoz, a Novartis company, announced that the US Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz) for all indications included in the reference product’s label.

Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The approval was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar to the US-licensed reference product. The approval of Zarxio follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC).

“The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” said Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz. “As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”

“Filgrastim has proven clinical value in treating patients at increased risk of neutropenia, but it is underused in the US for a variety of reasons, including price” said Dr. Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University. “Biosimilars have the potential to increase access and the approval of Zarxio may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice.”

Marketed as Zarzio® outside of the US, the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide, has generated over 7.5 million patient-days of exposure and is the most widely used filgrastim in Europe.

Source: Sandoz press release.