Interferon beta-1a
Encyclopedia
Interferon beta-1a is a drug in the interferon
family used to treat multiple sclerosis
(MS). It is produced by mammalian cells, while Interferon beta-1b
is produced in modified E. coli. Interferons have been shown to produce about a 18–38% reduction in the rate of MS relapses, and to slow the progression of disability in MS patients. There is currently no cure for MS, though starting a course of interferons early may slow its progress.
Interferon beta-1a is sold under the trade names Avonex (Biogen Idec
) and Rebif (Merck Serono
); CinnoVex
(CinnaGen
) is biosimilar
.
properties. Studies have also determined that Interferon beta improves the integrity of the blood-brain barrier
(BBB), which generally breaks down in MS patients, allowing increasing amounts of undesirable substances to reach the brain. This strengthening of the BBB may be a contributing factor to Interferon-Beta's beneficial effects. These studies were carried out in vitro
and thus may not necessarily work the same way in people.
The most commonly reported side effects are injection site disorders, flu-like
symptoms, poor results on liver function tests
, and blood cell
abnormalities. More serious side effects include depression, seizure
s, or liver
problems.
The two main side effects are flu-like symptoms and injection-site reactions. The flu-like symptoms tend to happen immediately after the injection and last for about half a day. In many patients, these symptoms diminish over time, but some patients continue to experience them over the long term. One can mitigate these symptoms by using a dose that is injected less frequently and by taking the medication before bedtime. The injection-site reactions can be mitigated by rotating injection sites or by using one of the medications that requires less frequent injections. Side effects are often onerous enough that many patients ultimately discontinue taking Interferons (or glatiramer acetate
, a comparable disease-modifying therapies requiring regular injections).
While these drugs improve certain diagnostic test results they do not cure MS and many patients report no perceived improvement and serious side-effects
that substantially reduce quality of life. Over time, physiological tolerance
and reduced effectiveness can occur due to the development of antibodies
to the drugs and side effects may persist even after discontinuation.
A one-month supply of Avonex or Rebif can cost from $1,600 to more than $3,000 USD.
biotechnology
company, originally under competition protection in the US under the Orphan Drug Act.
Avonex is sold in two formulations, a lyophilized powder requiring reconstitution and a pre-mixed liquid syringe kit; it is administered once per week via intramuscular injection
.
and Pfizer
in the US under an exception to the Orphan Drug Act. It was approved in Europe in 1998 and in the US in 2002 and is registered in more than 80 countries worldwide. Rebif is administered via subcutaneous injection
three times per week, and can be stored at room temperature for up to 30 days.
is the trade name of recombinant Interferon beta 1-a, which is manufactured as biosimilar/biogeneric in Iran
. It is produced in a lyophilized form and sold with distilled water
for injection. Cinnovex was developed at the Fraunhofer Institute
in collaboration with CinnaGen
, and is the first therapeutic protein from a Fraunhofer laboratory
to be approved as biogeneric / biosimilar medicine. A more water-soluble variant is currently being investigated by the Vakzine Projekt Management (VPM) GmbH in Braunschweig, Germany.
, also may be indicated for Multiple Sclerosis, and with a very similar drug profile. Interferon beta-1b is marketed only by Bayer
in the US as Betaseron and outside the US as Betaferon.
Extavia is a new brand of interferon beta-1b to be marketed by Novartis
beginning in 2009.
Interferon
Interferons are proteins made and released by host cells in response to the presence of pathogens—such as viruses, bacteria, or parasites—or tumor cells. They allow communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors.IFNs belong to...
family used to treat multiple sclerosis
Multiple sclerosis
Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
(MS). It is produced by mammalian cells, while Interferon beta-1b
Interferon beta-1b
Interferon beta-1b is a drug in the interferon family used to treat the relapsing-remitting and secondary-progressive forms of multiple sclerosis . It is approved for use after the first MS event...
is produced in modified E. coli. Interferons have been shown to produce about a 18–38% reduction in the rate of MS relapses, and to slow the progression of disability in MS patients. There is currently no cure for MS, though starting a course of interferons early may slow its progress.
Interferon beta-1a is sold under the trade names Avonex (Biogen Idec
Biogen Idec
Biogen Idec, Inc. is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen Inc. and San Diego, California-based IDEC Pharmaceuticals...
) and Rebif (Merck Serono
Merck Serono
Merck Serono is a pharmaceutical company headquartered in Geneva, Switzerland. In September 2006, Merck KGaA announced its intent to purchase the majority of Serono shares from Ernesto Bertarelli and the Bertarelli family. The Merck-Serono merger was announced on September 21, 2006...
); CinnoVex
CinnoVex
CinnoVex is the trade name of recombinant Interferon beta 1-a, which is manufactured as biosimilar in Iran.- Description :An interferon-beta protein developed at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Stuttgart, Germany, in collaboration with CinnaGen company,...
(CinnaGen
CinnaGen
CinnaGen is an Iran based biotechnology company, the biggest in the region.It has more than 14 years of experience in manufacturing of molecular biology, biopharmaceuticals and diagnostic products...
) is biosimilar
Biosimilar
Biosimilars or follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars are also referred to as subsequent entry biologics ...
.
Overview
It is believed that Interferon beta based drugs achieve their beneficial effect on MS progression via their anti-inflammatoryInflammation
Inflammation is part of the complex biological response of vascular tissues to harmful stimuli, such as pathogens, damaged cells, or irritants. Inflammation is a protective attempt by the organism to remove the injurious stimuli and to initiate the healing process...
properties. Studies have also determined that Interferon beta improves the integrity of the blood-brain barrier
Blood-brain barrier
The blood–brain barrier is a separation of circulating blood and the brain extracellular fluid in the central nervous system . It occurs along all capillaries and consists of tight junctions around the capillaries that do not exist in normal circulation. Endothelial cells restrict the diffusion...
(BBB), which generally breaks down in MS patients, allowing increasing amounts of undesirable substances to reach the brain. This strengthening of the BBB may be a contributing factor to Interferon-Beta's beneficial effects. These studies were carried out in vitro
In vitro
In vitro refers to studies in experimental biology that are conducted using components of an organism that have been isolated from their usual biological context in order to permit a more detailed or more convenient analysis than can be done with whole organisms. Colloquially, these experiments...
and thus may not necessarily work the same way in people.
The most commonly reported side effects are injection site disorders, flu-like
Influenza
Influenza, commonly referred to as the flu, is an infectious disease caused by RNA viruses of the family Orthomyxoviridae , that affects birds and mammals...
symptoms, poor results on liver function tests
Liver function tests
Liver function tests , are groups of clinical biochemistry laboratory blood assays designed to give information about the state of a patient's liver. The parameters measured include PT/INR, aPTT, albumin, billirubin and others...
, and blood cell
Red blood cell
Red blood cells are the most common type of blood cell and the vertebrate organism's principal means of delivering oxygen to the body tissues via the blood flow through the circulatory system...
abnormalities. More serious side effects include depression, seizure
Seizure
An epileptic seizure, occasionally referred to as a fit, is defined as a transient symptom of "abnormal excessive or synchronous neuronal activity in the brain". The outward effect can be as dramatic as a wild thrashing movement or as mild as a brief loss of awareness...
s, or liver
Liver
The liver is a vital organ present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of biochemicals necessary for digestion...
problems.
The two main side effects are flu-like symptoms and injection-site reactions. The flu-like symptoms tend to happen immediately after the injection and last for about half a day. In many patients, these symptoms diminish over time, but some patients continue to experience them over the long term. One can mitigate these symptoms by using a dose that is injected less frequently and by taking the medication before bedtime. The injection-site reactions can be mitigated by rotating injection sites or by using one of the medications that requires less frequent injections. Side effects are often onerous enough that many patients ultimately discontinue taking Interferons (or glatiramer acetate
Glatiramer acetate
Glatiramer acetate is an immunomodulator drug currently used to treat multiple sclerosis...
, a comparable disease-modifying therapies requiring regular injections).
While these drugs improve certain diagnostic test results they do not cure MS and many patients report no perceived improvement and serious side-effects
Adverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
that substantially reduce quality of life. Over time, physiological tolerance
Physiological tolerance
Physiological tolerance or drug tolerance is commonly encountered in pharmacology, when a subject's reaction to a drug is reduced at a later time even though the dose or concentration at the effect site is the same. This means that larger doses are required to achieve the same effect...
and reduced effectiveness can occur due to the development of antibodies
Antibody
An antibody, also known as an immunoglobulin, is a large Y-shaped protein used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. The antibody recognizes a unique part of the foreign target, termed an antigen...
to the drugs and side effects may persist even after discontinuation.
A one-month supply of Avonex or Rebif can cost from $1,600 to more than $3,000 USD.
Avonex
Avonex was approved in the US in 1996, and in Europe in 1997, and is registered in more than 80 countries worldwide. It is the leading MS therapy in the US, with around 40% of the overall market, and in Europe, with around 30% of the overall market. It is produced by the Biogen IdecBiogen Idec
Biogen Idec, Inc. is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen Inc. and San Diego, California-based IDEC Pharmaceuticals...
biotechnology
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
company, originally under competition protection in the US under the Orphan Drug Act.
Avonex is sold in two formulations, a lyophilized powder requiring reconstitution and a pre-mixed liquid syringe kit; it is administered once per week via intramuscular injection
Intramuscular injection
Intramuscular injection is the injection of a substance directly into a muscle. In medicine, it is one of several alternative methods for the administration of medications . It is used for particular forms of medication that are administered in small amounts...
.
Rebif
Rebif is a disease-modifying drug (DMD) used to treat multiple sclerosis in cases of clinically isolated syndromes as well as relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. It is co-marketed by Merck SeronoMerck Serono
Merck Serono is a pharmaceutical company headquartered in Geneva, Switzerland. In September 2006, Merck KGaA announced its intent to purchase the majority of Serono shares from Ernesto Bertarelli and the Bertarelli family. The Merck-Serono merger was announced on September 21, 2006...
and Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
in the US under an exception to the Orphan Drug Act. It was approved in Europe in 1998 and in the US in 2002 and is registered in more than 80 countries worldwide. Rebif is administered via subcutaneous injection
Subcutaneous injection
A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, collectively referred to as the...
three times per week, and can be stored at room temperature for up to 30 days.
CinnoVex
CinnoVexCinnoVex
CinnoVex is the trade name of recombinant Interferon beta 1-a, which is manufactured as biosimilar in Iran.- Description :An interferon-beta protein developed at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Stuttgart, Germany, in collaboration with CinnaGen company,...
is the trade name of recombinant Interferon beta 1-a, which is manufactured as biosimilar/biogeneric in Iran
Iran
Iran , officially the Islamic Republic of Iran , is a country in Southern and Western Asia. The name "Iran" has been in use natively since the Sassanian era and came into use internationally in 1935, before which the country was known to the Western world as Persia...
. It is produced in a lyophilized form and sold with distilled water
Distilled water
Distilled water is water that has many of its impurities removed through distillation. Distillation involves boiling the water and then condensing the steam into a clean container.-History:...
for injection. Cinnovex was developed at the Fraunhofer Institute
Fraunhofer Society
The Fraunhofer Society is a German research organization with 60 institutes spread throughout Germany, each focusing on different fields of applied science . It employs around 18,000, mainly scientists and engineers, with an annual research budget of about €1.65 billion...
in collaboration with CinnaGen
CinnaGen
CinnaGen is an Iran based biotechnology company, the biggest in the region.It has more than 14 years of experience in manufacturing of molecular biology, biopharmaceuticals and diagnostic products...
, and is the first therapeutic protein from a Fraunhofer laboratory
Fraunhofer Society
The Fraunhofer Society is a German research organization with 60 institutes spread throughout Germany, each focusing on different fields of applied science . It employs around 18,000, mainly scientists and engineers, with an annual research budget of about €1.65 billion...
to be approved as biogeneric / biosimilar medicine. A more water-soluble variant is currently being investigated by the Vakzine Projekt Management (VPM) GmbH in Braunschweig, Germany.
Related drugs
Closely related is Interferon beta-1bInterferon beta-1b
Interferon beta-1b is a drug in the interferon family used to treat the relapsing-remitting and secondary-progressive forms of multiple sclerosis . It is approved for use after the first MS event...
, also may be indicated for Multiple Sclerosis, and with a very similar drug profile. Interferon beta-1b is marketed only by Bayer
Bayer
Bayer AG is a chemical and pharmaceutical company founded in Barmen , Germany in 1863. It is headquartered in Leverkusen, North Rhine-Westphalia, Germany and well known for its original brand of aspirin.-History:...
in the US as Betaseron and outside the US as Betaferon.
Extavia is a new brand of interferon beta-1b to be marketed by Novartis
Novartis
Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland, ranking number three in sales among the world-wide industry...
beginning in 2009.