Bringing Access to Biologics
ISTANBUL, December 23, 2017 /PRNewswire/ —
Abdi Ibrahim Remede Pharma (AIRP) is Biocon’s partner in Algeria for the registration, marketing and pharmacovigilance monitoring of multiple Biotech Products. In 2016, AIRP launched the first Biosimilar of Trastuzumab (CANMAb®) in Algeria for the treatment of Her2+ breast cancer. Biocon‘s trastuzumab (filed and marketed through its US partner) is now approved by US FDA.
Our partner for Biologics, Biocon Ltd., Asia’s premier biopharmaceuticals company, obtained U.S. Food and Drug Administration (FDA) approval on 1st December 2017 for its biosimilar trastuzumab through its US Partner.
Biocon’s trastuzumab has been approved in the US for all indications included in the label of the reference product including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
Biocon’s trastuzumab is the first FDA-approved biosimilar trastuzumab and the first biosimilar from Biocon´s portfolio to be approved in the U.S. It is only the second oncology biosimilar approved by US FDA. It received FDA approval after a 16-0 favorable vote by the Oncology Drugs Advisory Committee (ODAC), consisting of oncologists, pharmacologists, statisticians, manufacturing and other experts. In addition, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for Biocon’s proposed biosimilar trastuzumab for review.
Abdi Ibrahim Remede Pharma (AIRP) as Biocon’s commercialization partner in Algeria launched the first biosimilar of trastuzumab named CANMAb® in 2016. Under its collaboration with Biocon in Algeria, AIRP also launched the first biosimilar of insulin glargine named BasalogOne® in 2017. Both these products are making a difference to patients by allowing them access to affordable biologics for diseases like diabetes and cancer.
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The global biologics drug market stands at an estimated US$ 231 billion. Under collaboration with Biocon, AIRP’s biosimilars operate in the biologics market which is valued over one third of the US$1 billion total Algeria pharma market.
The introduction and strong adoption of biosimilars in Algeria is expected to facilitate access to safe and effective biological products as well as create substantial savings for the government. In Europe, with over a decade of experience, biosimilar adoption rates have climed over 90% in certain countries and have significantly increased patient access to important, life-saving biologic therapies. It is estimated that regulations on biosimilars adapted to the country’s health and economic interests will enable Algeria to reduce its import bill by at least US$ 350 million in 2018 alone.
Abdi Ibrahim Remede Pharma
Abdi Ibrahim Remède Pharma (AIRP) was created in December 2014 from the merger of two Algerian-Turkish companies:
Abdi Ibrahim: A leading pharmaceutical company in the Turkish market, for the last 15 consecutive years. Established in 1912, more than 100 years of expertise in the pharmaceutical sector. Present on the Algerian market since 1999.
Remède Pharma, a local Algerian pharmaceutical company, created in 2004, specialized in urology, Iron & CNS, locally produced.
AIRP provides to the healthcare professional and to patients high quality products and services that meet their needs, improve quality of life and facilitate care.
The plant is built on an area of 6,000 m2, with modern equipment and qualification for the manufacture of a wide range of products in liquid, solid and semi-solid forms. The annual production capacity of this plant is 45 million units that will meet and exceed the needs of the domestic market and thus offer wide export opportunities for these other forms of drugs. The cost of the investment is approximately 25 million US dollars.
http://www.medicinesforeurope.com/wp-content/uploads/2017/05/IMS-Biosimilar-2017_V9.pdf, accessed 13 December 2017
SOURCE Abdi Ibrahim Remede Pharma