Pembuat Ozempic sedang mencoba memblokir versi gabungan dari obat blockbusternya


Produsen obat Novo Nordisk mengambil tindakan untuk mengekang industri senyawa semaglutide yang populer, yang menawarkan salinan obat penurun berat badan terlaris Ozempic dan Wegovy kepada pasien, seringkali dengan harga yang jauh lebih rendah.

Perusahaan farmasi asal Denmark ini sedang melobi Badan Pengawas Obat dan Makanan AS (FDA) untuk menambahkan semaglutide ke dalam daftar Demonstrable Compounding Facilities (DDC) yang dikeluarkan badan tersebut, sehingga akan mencegah apotek peracik memproduksi obat versi generik. Dalam sebuah dokumen yang dirilis oleh badan tersebut pada hari Selasa, pengacara Novo Nordisk berpendapat bahwa semaglutide termasuk dalam daftar tersebut “karena kompleksitas formulasinya,” dan beberapa alasan lainnya.

“Sintesis yang aman dari obat-obatan ini pada dasarnya rumit dan risiko yang ditimbulkannya terhadap keselamatan pasien jauh lebih besar daripada manfaatnya. Tujuan Novo Nordisk dengan nominasi ini adalah untuk memastikan bahwa pasien hanya menerima produk semaglutide yang disetujui FDA, aman dan efektif.

Petugas pers FDA Amanda Hils mengatakan kepada Wired melalui email bahwa badan tersebut “sedang meninjau petisi dan akan menanggapi langsung pemohon.”

Jika disetujui, penunjukan tersebut akan berdampak besar pada industri peracikan dan jutaan orang yang saat ini menggunakan obat gabungan GLP-1.

Obat suntik GLP-1 seperti semaglutide dan tezepatide telah mengalami kelangkaan sejak tahun 2022 karena popularitasnya. Di Amerika Serikat, ketika FDA menyatakan kekurangan suatu obat, apotek berlisensi tertentu diizinkan untuk memproduksi versi obat yang “diracik”, yang dicampur sendiri dan seharusnya mengandung bahan aktif yang sama dengan obat aslinya.

Penyedia telemedis memanfaatkan kekurangan obat GLP-1 untuk menawarkan versi gabungan kepada pasien melalui janji temu virtual yang cepat. Praktik ini telah menimbulkan ketegangan dengan perusahaan farmasi yang memproduksi obat-obatan bermerek, karena versi gabungannya dijual dengan harga yang jauh lebih rendah. Tanpa asuransi, Ozempic dan Wegovy berharga sekitar $1.000 per bulan, sedangkan senyawa semaglutide diiklankan secara online hanya dengan $100 per bulan.

Berbeda dengan obat generik yang diproduksi setelah masa paten suatu obat habis, obat majemuk tidak memerlukan persetujuan FDA sebelum dipasarkan. Artinya FDA tidak dapat menjamin keamanan, efektivitas, atau kualitas obat racikan sebelum dijual kepada pasien. FDA telah menerima banyak laporan tentang efek samping yang merugikan, termasuk rawat inap, terkait dengan kemungkinan kesalahan dosis pada produk co-semaglutide.



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