Oleh admin kalbemed pada August 03, 2018 06:00

Insulin Biosimilar dan Tantangan yang Dihadapi

Terapi insulin, tidak seperti obat lainnya, merupakan suatu hormon dan dibuat dengan menggunakan makhluk hidup. Suatu terapi yang dibuat dengan menggunakan makhluk hidup disebut sebagai produk biologis. Berdasarkan artikel yang dipublikasikan di American Diabetes Association, insulin biosimilar adalah suatu produk insulin yang sangat mirip dengan produk original atau referensi yang telah dipasarkan sebelumnya, dan tidak memiliki perbedaan yang bermakna secara klinis (baik efikasi dan keamanan) dengan produk referensinya tersebut. Mereka dikatakan analog seperti bagaimana produk generik yang memiliki molekul kecil analog dengan produk inovatornya.

Semakin banyak produk biosimilar insulin yang bermunculan di pasaran, seiring dengan off patent dari produk inovator atau pendahulunya. Insulin yang bermunculan ini tidak boleh disebut sebagai produk/obat generik karena mereka berbeda dengan obat generik. Insulin memiliki molekul yang besar dan molekul ini terlalu besar dan kompleks untuk dibuat secara kimiawi. Insulin ini harus dibuat menggunakan makhluk hidup seperti bakteri atau jamur.

Perusahaan yang membuat insulin biosimilar ini memiliki teknik manufacturing yang mirip namun tidak identik dengan pemegang produk patennya. Produk biosimilar dan inovatornya akan memiliki rangkaian asam amino yang sama, namun memiliki beberapa karakteristik molekul yang berbeda dan memiliki kerja yang bisa sedikit berbeda.

Suatu produk biologis dikatakan saling menggantikan atau interchangeable, adalah selain produk tersebut telah mencapai standar biosimilarity, produk tersebut juga diharapkan dapat memberikan hasil klinis yang sama seperti produk referensinya pada pasien manapun. Jikalau suatu produk diberikan kepada pasien lebih dari sekali, risiko dalam hal keamanan dan efektivitas dari produk biologis tersebut dan produk referensinya tidak lebih besar daripada risiko menggunakan produk referensi tanpa menggantinya sama sekali. Informasi tersebut dapat dilihat pada sitasi nomor 2.

Jadi apakah produk biosimilar insulin bisa menggantikan produk inovatornya? Lebih tepatnya lagi pertanyaan yang sering muncul adalah, apakah pasien yang sudah menggunakan produk inovatornya, boleh diberikan atau diganti ke produk biosimilar?

Dalam situs FDA dikatakan bahwa, jika produk biologis ingin dianggap interchangeable, maka perusahaan pembuatnya harus mendaftarkan permohonan tersebut, dengan menyertakan data sebagai berikut: informasi yang menunjukkan biosimilaritas berdasarkan data studi analitikal, studi pada hewan dan studi klinis seperti studi imunogenisitas dan PK/PD; data menunjukkan produk yang diajukan sebagai interchangeable memiliki hasil klinis yang sama dengan produk inovator pada pasien manapun; data yang menunjukkan bahwa risiko dalam hal keamanan atau penurunan efektivitas dari mengganti atau sebagai alternatif antara produk biologis yang akan diajukan sebagai interchangeable dan produk inovatornya adalah tidak besar dibandingkan risiko menggunakan produk inovator saja, tanpa mengganti-gantinya.

Studi dilakukan dalam desain crossover. Sangat penting untuk dicatat bahwa jika pasien mengalami respons imunitas atau kejadian tidak diinginkan selama periode studi crossover atau switching ini, suatu efek carryover akan membuat kita sulit menentukan apakah produk yang diajukan interchangeable tersebut ataukah produk inovatornya yang menimbulkan efek ini. Sehingga jika muncul kejadian tersebut pada kedua kelompok, akan menimbulkan perhatian apakah produk yang diajukan interchangeable dapat dianggap interchangeable, tidak terpisah apakah akibat dari produk yang diajukan ataukah akibat dari metode studi crossover yang dilakukan yang sebenarnya menimbulkan kejadian adverse event ini.

Produk biosimilar ini akan menciptakan pasar yang kompetitif, seperti molekul generik, karena memiliki harga yang lebih rendah dibandingkan inovatornya. Insulin biosimilar berpotensi untuk mengurangi biaya terapi pasien diabetes, meningkatkan akses akan terapi insulin terutama bagi pasien di daerah pedalaman dan menambah pilihan terapi insulin karena semakin banyak brand yang telah tersedia di pasaran dimiliki oleh perusahaan yang berbeda-beda. Namun produk biosimilar insulin inipun memiliki kendalanya sendiri. Mereka harus mengatasi berbagai rintangan peraturan, memenuhi berbagai tuntutan komersial, dan secara efektif menghadapi persaingan dari produk insulin bermerek dan generasi berikutnya sebelum mereka dapat berhasil di pasar global. [PMP]



Image: Ilustrasi
Referensi:
1. Biosimilar insulin [Internet]. 2017 [cited 2017 Oct 6]. Available from : https://www.diabetesdaily.com/learn-about-diabetes/insulin-101/biosimilar-insulin/.
2. Information for consumers (biosimilars) [Internet]. 2017 [cited 2017 Oct 16]. Available from: https://www.fda.gov/Drugs/ DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm.
3. Considerations in demonstrating interchangeability with a reference product guidance for industry. Draft guidance [Internet] 2017 [cited 2017 Oct 16]. Available from:https://www.fda.gov/downloads/Drug/GuidanceComplianceRegulatoryInfor
mation/Guidances/UCM537135.pdf.

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