January 6, 2022 News by Marisa Wexler, MS Generics of Gilenya Not Likely in US for at Least Another Two Years A decision by the U.S. Court of Appeals for the Federal Circuit has upheld the validity of a patent for dosing Novartis’ oral multiple sclerosis (MS) treatment Gilenya (fingolimod), the medication’s manufacturer announced. “With this decision, Novartis confirms that it expects no generic versions of Gilenya in the…
October 8, 2020 News by Sara Guariglia FDA Approves Lupin’s Generic Form of Tecfidera for MS Treatment Lupin‘s generic equivalent ofĀ Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment ofĀ multiple sclerosis (MS), the company announced in a press release. The therapy ā dimethyl fumarate delayed-release capsules ā is indicated for use in people withĀ clinically…
September 29, 2020 News by Joana Carvalho, PhD FDA Approves Generic of Tecfidera for Adults With Relapsing MS The U.S. Food and Drug Administration (FDA) has approved Ciplaās dimethyl fumarate capsules, a generic version of Biogenās Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in aĀ press release. This generic is packagedĀ as 120 mg or 240 mg…
August 20, 2020 News by Marisa Wexler, MS Mylan Launching Tecfidera Generic in US Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid ā…
November 7, 2019 News by Patricia Inacio, PhD Generic Version of Gilenya, pms-Fingolimod, Now Available for RRMS Patients in Canada PharmascienceĀ recently launched pms-Fingolimod, a generic version of NovartisāĀ GilenyaĀ (fingolimod),Ā to treat adults with relapsing-remitting multiple sclerosisĀ (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya. GenericĀ medicines are chemically identical to the original branded therapy, but carry a…
November 20, 2018 News by Alice MelĆ£o, MSc FDA Approves Generic Version of Aubagio to Treat Relapsing MS, Glenmark Pharma Says The U.S. Food and Drug Administration (FDA) has approved a generic version of Ā Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer,Ā Glenmark Pharmaceuticals. The FDAās decision to approve the company’s application for teriflunomide tablets at two…
September 25, 2018 News by Janet Stewart, MSc Dalfampridine ER Tablets, Generic Version of Ampyra, Now Available in US, Mylan Announces Mylan announced its U.S. launch of dalfampridine extended-release (ER) tablets, the authorized generic version of Acorda‘s Ampyra, that work to improve walking abilities in adults with multiple sclerosis (MS). Both versions of this medication come in a 10 mg tablet form. Approved generic medicinesĀ are those that…
September 18, 2018 Columns by Ed Tobias A Generic for Ampyra Could Be Released Soon Editorās note: Shortly after this column was published, Mylan pharmaceuticals announced it will begin distributing Dalfampridine Extended-Release Tablets, 10 mg, the authorized generic version of Acordaās Ampyra. Thereās been no word, yet, on what it will cost or how soon the generic will become available in pharmacies. A few…
July 27, 2018 News by Alice MelĆ£o, MSc Oral DMTs Still Common 1st Therapy for New MS Patients but Ocrevus Having Impact, Market Report Says Oral disease-modifying therapies (DMTs) are the most common first choice of treatment for people newly diagnosed with multiple sclerosis (MS) in the United States, an analysis reports. Antibody-based DMTs like Ocrevus, however, are emerging competitors. Spherix Global Insights, a market research and analysis company, states that 1 in every…
February 15, 2018 News by Patricia Silva, PhD FDA Approves Dose of MS Therapy Glatopa That Is Twice as Large as Current One The U.S. Food and Drug Administration has approved a new dose ofĀ Sandozās multiple sclerosis therapyĀ Glatopa (glatiramer acetate injection)Ā that is twice as large as the currently authorized one. Regulators’ approval of theĀ 40 mg/mL applies to people with relapsing forms of MS. A mg/mL designation refers to the concentration of…
January 26, 2018 News by Jose Marques Lopes, PhD Brabio, 1st Generic Version of Copaxone for Relapsing MS, Launched in UK Brabio (glatiramer acetate injection), the first generic alternative to CopaxoneĀ for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker,Ā Mylan, announced. Similar to Copaxone Ā ā developed by TevaĀ āĀ Brabio is now available at a 40 mg/ml dose. Both medications are…
December 15, 2017 News by Patricia Silva, PhD Ocrevus’ Use Continues Rising, with RRMS Patients Receiving the Most Attention U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global InsightsĀ reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.
October 5, 2017 News by Patricia Silva, PhD FDA Approves Mylanās Generic Copaxone, Introducing First Generic High-Dose Version The U.S. Food and Drug Administration has approved both lower and higher doses ofĀ Mylanās generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL ā intended for…
September 18, 2017 News by Patricia Silva, PhD Synthon Wins EU Patent Case Against Teva, Paving Way for Generic Copaxone for MS Patients AĀ European Patent OfficeĀ decision has opened the door toĀ SynthonĀ providing cheaper generic versions of Teva Pharmaceuticalās Copaxone to people withĀ relapsing multiple sclerosis. What looks like the final hurdle to the generics was cleared when the patent office’sĀ Technical Board of Appeal revoked the last of the patents that Teva…
January 30, 2017 News by Patricia Inacio, PhD Generic Form of Copaxone, GTR, Safe and Effective, Study Confirms An extension trial assessing generic glatiramer acetate (GTR) treatment in multiple sclerosis (MS) patients found that the formulation is as safe and effective as Copaxone (branded glatiramer acetate), and that switching to GTR is well-tolerated. The findingsĀ were in theĀ study, āSwitching from branded to generic glatiramer acetate:…
September 9, 2016 News by Patricia Silva, PhD 1st Generic for Copaxone to Treat Relapsing MS Available in Central and Eastern Europe AlvogenĀ recently announced the launch of Remurel (glatiramer acetate) in Central and Eastern Europe, making it the first generic equivalent of Copaxone Ā to be clinically validated for the treatment of relapsing forms of multiple sclerosis (RRMS) in Europe. European health authorities determined that Remurel 20 mg was the therapeutic equivalent…
October 20, 2015 News by Patricia Inacio, PhD Generic Form of Glatiramer Acetate Has Equivalent Gene Expression Profile as Teva’s Copaxone In a recent study entitled āEquivalent Gene Expression Profiles between Glatopaā¢ and CopaxoneĀ®,ā authors determined potential differences in treatment responses by investigating the gene expression profile of two approved treatments for relapsing forms of multiple sclerosis ā Copaxone and Glatopa. Both of these MS therapies are glatiramer…
August 4, 2015 News by Patricia Silva, PhD Pfizer Acquires Exclusive Commercialization Rights to Generic Copaxone for Relapsing Remitting Multiple Sclerosis Netherlands-based international pharmaceutical company Synthon, best known for developing complex generic therapeutics, has officially entered into an agreement with pharmaceutical giant Pfizer, Inc., effectively transferring the exclusive rights in the US to glatiramer acetate to Pfizer. Glatiramer acetate is an experimental generic formulation of Copaxone, which is indicated as a…
April 17, 2015 News by Patricia Silva, PhD First Generic Version of Copaxone Approved by FDA to Treat Multiple Sclerosis The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version ofĀ CopaxoneĀ (glatiramer acetate injection) for the treatment ofĀ relapsing forms of multiple sclerosis (MS). The administration has grantedĀ Sandoz marketing authorization forĀ glatiramer acetate in 20 mg/1 ml…
December 1, 2014 News by Patricia Silva, PhD FDA Delays Ruling on Teva Petition Against Generic Copaxone for MS Teva Pharmaceutical Industries Ltd., the company behind multiple sclerosis drugĀ COPAXONEĀ® (glatiramer acetate injection), has been pursuing the US Food and Drug Administration‘s decision against approving a generic version of the drug, by Mylan, Inc.Ā Teva’s petition has been turned down several times,…